Benchmed logo
Benchmed

EpiLaze Multi-wavelength Laser

Rohrer Aesthetics

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

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

Rohrer Aesthetics
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
View list →

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K191162
Device name
EpiLaze Multi-wavelength Laser
Company
Rohrer Aesthetics
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-05-01
Decision date
2019-07-09
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The EpiLaze Multi-wavelength Laser is intended for use in dermatologic and general surgical procedures.

Indication for Use for the 1064nm wavelength:
• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for
- 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; and
- treatment of Pseudo folliculitis Barbae (PFB).

Indication for Use for the 810nm wavelength:
• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for 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.

Indication for use for the 755nm wavelength:
• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for 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.

The STANDARD mode can be used on all skin types (Fitzpatrick I-VI), including tanned skin. The SFT mode can only be used on Fitzpatrick skin type I-IV. Do not use the SFT mode on tanned skin.

Intended Use

The EpiLaze Multi-wavelength Laser is intended for use in dermatologic and general surgical procedures. Indication for Use for the 1064nm wavelength: The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for 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; and treatment of Pseudo folliculitis Barbae (PFB). Indication for Use for the 810nm wavelength: The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for 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. Indication for use for the 755nm wavelength: The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for 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. The STANDARD mode can be used on all skin types (Fitzpatrick I-VI), including tanned skin. The SFT mode can only be used on Fitzpatrick skin type I-IV. Do not use the SFT mode on tanned skin.

Summary parsed at:2026-06-01 05:55:19 UTC

Predicate devices

2
  • K123777

    MULTILASER SYSTEM

    —

  • K170626

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

    Alma Lasers, Inc.

K191162 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K191162 as a predicate