Accent Prime Ultra Applicator for Inc.

Basic Information

• Brand Name: Accent Prime Ultra Applicator for Inc.
• Primary DI: 07290110122348
• Version / Model: 1
• Catalog Number: AAAP07042215
• Company Name: ALMA LASERS LTD.
• Labeler DUNS: 532283264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-22
• Public Version: 2
• Public Version Date: 2025-06-30
• Public Version Status: Update
• Public Device Record Key: 8c6fc4a9-fe07-487e-9e74-f00123421b38

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5300	2
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290110122348	GS1

Premarket Submissions

Submission Number	Supplement Number
K160075	000