Benchmed logo
Categories

Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece

Alma Lasers, Inc.

Country / Region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

Summary PDF

Company

Alma Lasers, Inc. logoAlma Lasers, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3
View list →

Cited as predicate

2
View list →

Device details

FDA 510(k) registration fields

K number
K170626
Device name
Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
Company
Alma Lasers, Inc.
Country / Region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-03-02
Decision date
2017-05-31
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalVascular treatment
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Soprano 1064nm module is intended for use in dermatologic and general surgical procedures.

The indications for use for the 1064nm Diode Laser Module include:
 Permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen in HR and SHR Modes
 Treatment of Pseudo folliculitis Barbae (PFB)
 Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Intended Use

The Soprano 1064nm module is intended for use in dermatologic and general surgical procedures.

Device Description

The subject device, Alma Lasers Soprano 1064nm Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano ICE platform. The module's operation involves emission of laser (diode) energy through the handpiece to the patient's skin. The materials that could contact the patient during device use are sapphire, aluminum, and plastic; these would all have limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

Summary parsed at:2026-06-01 05:59:50 UTC

Predicate devices

3
  • K132185

    FAMILY OF COOLGLIDE AESTHETIC LASERS

    —

  • K140009

    SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM

    —

  • K153671

    Family of CoolGlide Aesthetic Lasers

    Cutera, Inc.

K170626 references 3 predicate/reference devices

Cited as predicate

2
  • K172193

    Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules

    Alma Lasers, Inc.

  • K191162

    EpiLaze Multi-wavelength Laser

    Rohrer Aesthetics, LLC

2 submissions cite K170626 as a predicate