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The AMSCO Warming Cabinet Standard Solid Dual 24-inch 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ040124331
In Commercial Distribution
- 00724995153977 ()
DJ040124331
- Multi-purpose warming cabinet, stationary
- Multi-purpose warming cabinet, recessed
The AMSCO Warming Cabinet Standard Solid Single 24-inch 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ030124131
In Commercial Distribution
- 00724995153953 ()
DJ030124131
- Multi-purpose warming cabinet, recessed
- Multi-purpose warming cabinet, stationary
The AMSCO Warming Cabinet Standard Solid Dual 18-inch 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ020124332
In Commercial Distribution
- 00724995153946 ()
DJ020124332
- Multi-purpose warming cabinet, recessed
- Multi-purpose warming cabinet, stationary
The AMSCO Warming Cabinet Standard Solid Single 18inch 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ010124132
In Commercial Distribution
- 00724995153939 ()
DJ010124132
- Multi-purpose warming cabinet, stationary
- Multi-purpose warming cabinet, recessed
No Description
AZENA MEDICAL, LLC
8990
Not in Commercial Distribution
- 00861407000389 ()
- Dental diode laser system
A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.
Biolase, Inc.
7400055 Refurbished
In Commercial Distribution
- 00647529002599 ()
- Musculoskeletal/physical therapy laser, professional
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054 Refurbished
In Commercial Distribution
- 00647529002575 ()
- General/multiple surgical diode laser system
A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.
Biolase, Inc.
7400055
In Commercial Distribution
- 00647529000267 ()
7400055
- Musculoskeletal/physical therapy laser, professional
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054
In Commercial Distribution
- 00647529000236 ()
7400054
- General/multiple surgical diode laser system
Upgrade Package, 660nm wavelength
DENTSPLY SIRONA ORTHODONTICS INC.
6661420
Not in Commercial Distribution
- D74666614201 ()
6661420
- Dental diode laser system
Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556
Not in Commercial Distribution
- D74666595561 ()
6659556
- Dental diode laser system
MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309
Not in Commercial Distribution
- D74666593091 ()
6659309
- Dental diode laser system
EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291
Not in Commercial Distribution
- D74666592911 ()
- D74666592910 ()
6659291
- Dental diode laser system
EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283
Not in Commercial Distribution
- D74666592831 ()
- D74666592830 ()
6659283
- Dental diode laser system
Laser protective goggle for patient
DENTSPLY SIRONA ORTHODONTICS INC.
6659242
Not in Commercial Distribution
- D74666592421 ()
6659242
- Dental diode laser system
Laser protective goggles for spectacle wearers
DENTSPLY SIRONA ORTHODONTICS INC.
6659234
Not in Commercial Distribution
- D74666592341 ()
6659234
- Dental diode laser system
Laser protective goggles
DENTSPLY SIRONA ORTHODONTICS INC.
6659226
Not in Commercial Distribution
- D74666592261 ()
6659226
- Dental diode laser system
Fibercutter
DENTSPLY SIRONA ORTHODONTICS INC.
6659218
Not in Commercial Distribution
- D74666592181 ()
6659218
- Dental diode laser system
EasyBend - Bending tool
DENTSPLY SIRONA ORTHODONTICS INC.
6659200
Not in Commercial Distribution
- D74666592001 ()
6659200
- Dental diode laser system
Optic protection cap for handpiece (5 pieces)
DENTSPLY SIRONA ORTHODONTICS INC.
6659192
Not in Commercial Distribution
- D74666591921 ()
- D74666591920 ()
6659192
- Dental diode laser system
Handpiece sleeve with keypad
DENTSPLY SIRONA ORTHODONTICS INC.
6659184
Not in Commercial Distribution
- D74666591841 ()
6659184
- Dental diode laser system
Sculpt I.Q. Laser, USA
DENTSPLY SIRONA ORTHODONTICS INC.
6659101
Not in Commercial Distribution
- D74666591011 ()
6659101
- Dental diode laser system
OMNILUX MEDICAL PLUS HEAD
LOTUS GLOBAL GROUP, INC, THE
EM1387
In Commercial Distribution
- B434EM1387 ()
- Musculoskeletal/physical therapy laser, professional
- Skin photodynamic therapy/phototherapy lamp
OMNILUX MEDICAL BASE
LOTUS GLOBAL GROUP, INC, THE
EM1258S
In Commercial Distribution
- B434EM1258S0 ()
- Musculoskeletal/physical therapy laser, professional
- Skin photodynamic therapy/phototherapy lamp
Hot and Heat
Therabody, Inc.
RecoveryTherm Cube
In Commercial Distribution
- 00840295401782 ()
- Electric pad localized-body heating system
- Hot/cold therapy pack, reusable
Upgrade Package, 660nm wavelength
DENTSPLY SIRONA ORTHODONTICS INC.
6661420G
Not in Commercial Distribution
- D8076661420G1 ()
6661420G
- Dental diode laser system
Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556G
Not in Commercial Distribution
- D8076659556G1 ()
6659556G
- Dental diode laser system
MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309G
Not in Commercial Distribution
- D8076659309G1 ()
6659309G
- Dental diode laser system
EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291G
Not in Commercial Distribution
- D8076659291G1 ()
- D8076659291G0 ()
6659291G
- Dental diode laser system
EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283G
Not in Commercial Distribution
- D8076659283G1 ()
- D8076659283G0 ()
6659283G
- Dental diode laser system
Laser protective goggle for patient
DENTSPLY SIRONA ORTHODONTICS INC.
6659242G
Not in Commercial Distribution
- D8076659242G1 ()
6659242G
- Dental diode laser system
Laser protective goggles for spectacle wearers
DENTSPLY SIRONA ORTHODONTICS INC.
6659234G
Not in Commercial Distribution
- D8076659234G1 ()
6659234G
- Dental diode laser system
Laser protective goggles
DENTSPLY SIRONA ORTHODONTICS INC.
6659226G
Not in Commercial Distribution
- D8076659226G1 ()
6659226G
- Dental diode laser system
Fibercutter
DENTSPLY SIRONA ORTHODONTICS INC.
6659218G
Not in Commercial Distribution
- D8076659218G1 ()
6659218G
- Dental diode laser system
EasyBend - Bending tool
DENTSPLY SIRONA ORTHODONTICS INC.
6659200G
Not in Commercial Distribution
- D8076659200G1 ()
6659200G
- Dental diode laser system
Optic protection cap for handpiece (5 pieces)
DENTSPLY SIRONA ORTHODONTICS INC.
6659192G
Not in Commercial Distribution
- D8076659192G1 ()
- D8076659192G0 ()
6659192G
- Dental diode laser system
Handpiece sleeve with keypad
DENTSPLY SIRONA ORTHODONTICS INC.
6659184G
Not in Commercial Distribution
- D8076659184G1 ()
6659184G
- Dental diode laser system
Sculpt I.Q. Laser, USA
DENTSPLY SIRONA ORTHODONTICS INC.
6659101G
Not in Commercial Distribution
- D8076659101G1 ()
6659101G
- Dental diode laser system
SMARTLUX MINI is the combination of low power beam irradiator and infrared irradiator, and it is KGMP, CE/MDD class IIa class medical equipment. Your attention to prevent danger or injury is required. Please read User’s Manual carefully before you use medical equipment, and if you have any questions on safety, application, or operation of the equipment, please contact MEDMIX Co., Ltd. or its distributor.
Medmix Co., Ltd.
D478000
Not in Commercial Distribution
- 08800077100045 ()
- Red-light phototherapy unit, professional
- Musculoskeletal infrared phototherapy unit, non-wearable
Diode 755nm Alex Applicator for Soprano Titanium (Black)
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110123526 ()
AASP28012401
- Dermatological diode laser system
The Alma Lasers Soprano Titanium Laser System consists of:
•System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts)
•Operator control panel with touch-screen technology (GUI)
•Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously
Premarket Notification Traditional 510(k) Section 8: Page 2 of 4
Alma Lasers Soprano Titanium
• 810 nm applicator
• 755 nm applicator
• Small NIR applicator
• Footswitch and other laser safety accessories
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121829 ()
AASP05091845BSR0001
- Dermatological diode laser system
- Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121812 ()
AASP30111208
- Dermatological diode laser system
- Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121676 ()
AAIR02031605
- Multi-modality skin surface treatment system
Nir Face (6) HP for Soprano Ice Platinum Edition\Titanium
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121669 ()
AAIR02031604
- Multi-modality skin surface treatment system
Diode 810nm Speed 2cm HP for Soprano Ice Platinum Edition / Titanium
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121652 ()
AASP30111205
- Dermatological diode laser system
Diode 755nm Alex 1.5cm HP for Soprano Ice Platinum Edition/Titanium
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121645 ()
AASP02031603
- Dermatological diode laser system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121638 ()
AASP02031602
- Dermatological diode laser system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121621 ()
AASP02031601
- Dermatological diode laser system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121614 ()
AASR11021407
- Radio-frequency skin/body contouring system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121607 ()
AASR11021401
- Radio-frequency skin/body contouring system