AccessGUDID - DEVICE: Accent Prime Ultra Applicator for Inc. (07290110122348)

GUDID

Device Identifier (DI) Information

Brand Name: Accent Prime Ultra Applicator for Inc.
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AAAP07042215
Company Name: ALMA LASERS LTD.

Primary DI Number: 07290110122348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532283264 *Terms of Use

Device Description: The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45591	Ultrasonic skin/body contouring system	An assembly of devices intended for the transdermal application of ultrasonic energy [e.g., high intensity focused ultrasound (HIFU)] to rupture subcutaneous fat cells to minimize the manifestation of cellulite, and/or to stimulate elastin/collagen production and tissue rejuvenation to improve the appearance of loose or wrinkled skin, and/or facial lines, for cosmetic purposes. The assembly typically consists of an electrically-powered generator, user controls/interface, and an ultrasonic transducer/handpiece; it may include a video imaging system to assist transducer positioning during treatment. This device may serve as a noninvasive outpatient procedure alternative to liposuction.	Active	false
45219	Radio-frequency skin/body contouring system	An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
ISA	Massager, Therapeutic, Electric
NUV	Massager, Vacuum, Light Induced Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160075	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c6fc4a9-fe07-487e-9e74-f00123421b38
Public Version Date: June 30, 2025
Public Version Number: 2
DI Record Publish Date: November 22, 2022