Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No.3 is indicated for the treatment of very small facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, also consisting of a plastic body with integrated electronic system, 3 electrodes and indication light guide ring.
POLLOGEN LTD
POLLOGEN LEGEND+
In Commercial Distribution

  • 07290016586039 ()
21400370

  • Radio-frequency skin surface treatment system
Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No.2 is indicated for the treatment of medium size facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, also consisting of a plastic body with integrated electronic system, 3 electrodes and indication light guide ring.
POLLOGEN LTD
POLLOGEN LEGEND+
In Commercial Distribution

  • 07290016586022 ()
21400270

  • Radio-frequency skin surface treatment system
Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring.
POLLOGEN LTD
POLLOGEN LEGEND+
In Commercial Distribution

  • 07290016586015 ()
20900270

  • Radio-frequency skin surface treatment system
The Pollogen Legend+ system is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3). Pollogen Legend+ system is composed of a console, VO hand held applicator and disposable tips, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins. It is also composed of 3 treatment applicators, foot switch and patient-controlled manual switch. User interface allows the selection of treatment parameters: applicator, power and time and displays the current settings. The RF module provides RF energy to applicators at 1 MHz frequency. The treatment applicators transmit Bi-Polar RF energy through multiple electrode configuration which produces homogenous heating of the treatment area.
POLLOGEN LTD
POLLOGEN LEGEND+
In Commercial Distribution

  • 07290016586008 ()
30009000U

  • Radio-frequency skin surface treatment system
No Description
VENUS CONCEPT LTD
VI102402NI
In Commercial Distribution

  • 07290016541540 ()


  • Radio-frequency skin surface treatment system
No Description
VENUS CONCEPT LTD
PK000132
In Commercial Distribution

  • 07290016541106 ()


  • Radio-frequency skin surface treatment system
No Description
VENUS CONCEPT LTD
PK000131
In Commercial Distribution

  • 07290016541090 ()


  • Radio-frequency skin surface treatment system
No Description
VENUS CONCEPT LTD
PK000130
In Commercial Distribution

  • 07290016541083 ()


  • Radio-frequency skin surface treatment system
No Description
VENUS CONCEPT LTD
AS110009GLB
In Commercial Distribution

  • 07290016541076 ()


  • Radio-frequency skin surface treatment system
No Description
VENUS CONCEPT LTD
AS110011GLB
In Commercial Distribution

  • 07290016541069 ()


  • Radio-frequency skin surface treatment system
No Description
VENUS CONCEPT LTD
VI102402GLB
In Commercial Distribution

  • 07290016541052 ()


  • Radio-frequency skin surface treatment system
No Description
VENUS CONCEPT LTD
AS112010
In Commercial Distribution

  • 07290016540697 ()
  • 07290016540741 ()


  • Radio-frequency skin surface treatment system
Venus Viva system with applicators
VENUS CONCEPT LTD
PK000044
In Commercial Distribution

  • 07290016540345 ()


  • Radio-frequency skin surface treatment system
Fractora 24P
INMODE M.D LTD
AG602426A
In Commercial Distribution

  • 17290016633150 ()
  • 07290016633153 ()
AG602426A

  • Radio-frequency skin surface treatment system
The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
Titan
In Commercial Distribution

  • 07290015763851 ()
  • 17290015763858 ()
  • 27290015763855 ()
7290015763851

  • Radio-frequency skin surface treatment system
The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
BellaVisage Hybrid
In Commercial Distribution

  • 17290112452013 ()
  • 07290112452016 ()
7290112452016

  • Radio-frequency skin surface treatment system
The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n Titan Allways is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n Titan AllWays device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
Titan AllWays
In Commercial Distribution

  • 17290112451559 ()
  • 07290112451552 ()
7290112451552

  • Radio-frequency skin surface treatment system
The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
BellaVisage
In Commercial Distribution

  • 17290112450224 ()
  • 07290112450227 ()
  • 27290112450221 ()
7290112450227

  • Radio-frequency skin surface treatment system
The Nutritone Facial Beauty System is a gentle rejuvenating treatment which provides your skin with gentle electronic stimulation.
Isomers Laboratories Inc
T300
In Commercial Distribution

  • 00884785000017 ()


  • Radio-frequency skin surface treatment system
EYE PREP TRAY, NEW YORK EYE & EAR
MEDLINE INDUSTRIES, INC.
DYNDP1094A
In Commercial Distribution

  • 20888277732725 ()
  • 10888277732728 ()
DYNDP1094A

  • General surgical procedure kit, non-medicated, single-use
Pack Mini Eye F/ Holland Eye Surgery
HENRY SCHEIN, INC.
5704770
In Commercial Distribution

  • 00304040190340 ()
  • 10304040190347 ()
5704770

  • General surgical procedure kit, non-medicated, single-use
TRAY,EYE PREP,NEW YORK EYE&EAR
MEDLINE INDUSTRIES, INC.
DYNDP1094
In Commercial Distribution

  • 10884389550588 ()
  • 40884389550589 ()
DYNDP1094

  • General surgical procedure kit, non-medicated, single-use
size 0 capsule suppository applicator, 6 total
Cristcot LLC
D0-6
In Commercial Distribution

  • 00850325006320 ()
  • 00850325006429 ()


  • Rectal medication applicator, single-use
Organic Cotton Carboard Applicator Tampons, Super, 14u
Sparkle Innovations Inc.
Applicator Super
In Commercial Distribution

  • 10850036179037 ()
  • 00850036179030 ()
  • 00850036179016 ()


  • Menstrual tampon, unscented
Organic Cotton Cardboard Applicator Tampons, Regular,16u
Sparkle Innovations Inc.
Applicator, Regular
In Commercial Distribution

  • 10850036179020 ()
  • 00850036179023 ()
  • 00850036179009 ()


  • Menstrual tampon, unscented
No Description
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Applicator Regular
In Commercial Distribution

  • 30050428354118 ()
  • 00050428354117 ()
  • 10050428354114 ()


  • Menstrual tampon, unscented
No Description
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Applicator Light
In Commercial Distribution

  • 00050428586747 ()
  • 30050428586748 ()
  • 10050428586744 ()


  • Menstrual tampon, unscented
No Description
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Applicator Regular
In Commercial Distribution

  • 00050428551196 ()
  • 30050428551197 ()
  • 10050428551193 ()


  • Menstrual tampon, unscented
No Description
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Applicator Super
In Commercial Distribution

  • 00050428550434 ()
  • 30050428550435 ()
  • 10050428550431 ()


  • Menstrual tampon, unscented
No Description
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Applicator Regular
In Commercial Distribution

  • 00050428516706 ()
  • 30050428516707 ()
  • 10050428516703 ()


  • Menstrual tampon, unscented
No Description
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Applicator Super
In Commercial Distribution

  • 00050428513279 ()
  • 30050428513270 ()
  • 10050428513276 ()


  • Menstrual tampon, unscented
No Description
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Applicator Super
In Commercial Distribution

  • 30050428368092 ()
  • 00050428368091 ()
  • 10050428368098 ()


  • Menstrual tampon, unscented
No Description
CORMAN SPA
Applicator Regular
In Commercial Distribution

  • 08016867008976 ()
  • 38016867008977 ()
  • 18016867008973 ()
  • 08016867007726 ()


  • Menstrual tampon, unscented
No Description
CORMAN SPA
Applicator Super
In Commercial Distribution

  • 08016867008969 ()
  • 38016867008960 ()
  • 18016867008966 ()
  • 08016867007733 ()


  • Menstrual tampon, unscented
No Description
CORMAN SPA
Applicator Super
In Commercial Distribution

  • 38016867007659 ()
  • 08016867007658 ()
  • 18016867007655 ()
  • 48016867007656 ()


  • Menstrual tampon, unscented
No Description
CORMAN SPA
Applicator Regular
In Commercial Distribution

  • 38016867007642 ()
  • 08016867007641 ()
  • 18016867007648 ()
  • 48016867007649 ()


  • Menstrual tampon, unscented
No Description
CORMAN SPA
Applicator Super
In Commercial Distribution

  • 38016867007246 ()
  • 08016867007245 ()
  • 18016867007242 ()


  • Menstrual tampon, unscented
No Description
CORMAN SPA
Applicator Regular
In Commercial Distribution

  • 38016867007239 ()
  • 08016867007238 ()
  • 18016867007235 ()


  • Menstrual tampon, unscented
No Description
CORMAN SPA
Applicator Super
In Commercial Distribution

  • 08016867006750 ()
  • 38016867006751 ()
  • 18016867006757 ()
  • 48016867006758 ()


  • Menstrual tampon, unscented
No Description
CORMAN SPA
Applicator Regular
In Commercial Distribution

  • 08016867006743 ()
  • 38016867006744 ()
  • 18016867006740 ()
  • 48016867006741 ()


  • Menstrual tampon, unscented
Farrell applicator, 5 1/2'', twist end
AMBLER SURGICAL CORP.
Farrell applicator
In Commercial Distribution

  • 00190660105815 ()
43-311

  • ENT probe, reusable
Farrell applicator, 5 1/2'', triangular end
AMBLER SURGICAL CORP.
Farrell applicator
In Commercial Distribution

  • 00190660105808 ()
43-310

  • ENT probe, reusable
Non-thermal radio frequency device for relief of minor aches and pains, relief of muscle spasms, temporary improvement in local circulation, and temporary reduction in the appearance of cellulite.
CAO GROUP, INC.
005-00036
In Commercial Distribution

  • 00872320004460 ()
  • 00872320004477 ()


  • Multi-modality skin contouring system
SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III
Candela Corporation
KT75672
In Commercial Distribution

  • 00817495024578 ()
KT75672

  • Multi-modality skin contouring system
SA Repl. Med. Cvr. 25x30mm (4 Hr), Velashape III
Candela Corporation
KT75072
In Commercial Distribution

  • 00817495024561 ()
  • 10817495024568 ()
KT75072

  • Multi-modality skin contouring system
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
Candela Corporation
AS83333
In Commercial Distribution

  • 00817495024462 ()


  • Multi-modality skin contouring system
SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
Candela Corporation
AS87512
In Commercial Distribution

AS87512

  • Multi-modality skin contouring system
Replaceable Cover, Vsmooth 4Hr, Velashape III
Candela Corporation
AS85993
In Commercial Distribution

AS85993

  • Multi-modality skin contouring system
LA Replaceable Cover (4 Hr) 5-Pk, Velashape III
Candela Corporation
KT75102
In Commercial Distribution

KT75102

  • Multi-modality skin contouring system
SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape III
Candela Corporation
KT75061
In Commercial Distribution

KT75061

  • Multi-modality skin contouring system
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