# K191162: EpiLaze Multi-wavelength Laser

- Pathway: 510(k) (Traditional)
- Applicant: Rohrer Aesthetics, LLC
- Decided: Jul 9, 2019 after 69 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K943450 (1995). 546 ancestors in all.
No later device cites it as a predicate yet.
0 of 547 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece, Alma Lasers, Inc. (2017) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K191162
Methodology: https://510kreport.com/methodology