# K201594: Primelase Excellence

- Pathway: 510(k) (Traditional)
- Applicant: High Technology Products S.L.U
- Decided: Dec 17, 2020 after 188 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: 24 generations back to K943450 (1995). 575 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 578 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191321: Primelase Excellence, High Technology Products S.L.U (2019) Summary page 5.
- 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. (2018) Summary page 5.
- K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity, Lumenis, Ltd. (2017) Summary page 6.

## Most influential descendants
- K241656: Eneka Selectif (2024), 1 descendant of its own
- K253251: Leaseir MHR Xcell  (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) (2026), 0 descendants of its own

## Indications for use
Intended Use: PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures. Indications for Use: PRIMELASE Excellence System with 810nm Laser applicator is intended for: * Hair Removal with Static and Dynamic modes 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 regime. * Treatment of Pseudofolliculitis barbae (PFB). * Use on all skin types (Fitzpatrick 1-VI). * Treatment of benign pigmented lesions PRIMELASE Excellence System with 755nm Laser applicator is intended for: * Hair Removal with Static and Dynamic modes 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 regime. * Treatment of Pseudofolliculitis barbae (PFB). * Use on all skin types (Fitzpatrick I-VI). * Treatment of benign pigmented lesions PRIMELASE Excellence System with 1060nm Laser applicator is intended for: * Hair Removal with Static and Dynamic modes 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 regime. * Treatment of Pseudofolliculitis barbae (PFB). » Use on all skin types (Fitzpatrick I-VI). * Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia, and other benign vascular lesions and leg veins. * Treatment of wrinkles PRIMELASE Excellence System with 810-1060nm Laser applicator is intended for: * Hair Removal with Static and Dynamic modes 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 regime. * Treatment of Pseudofolliculitis barbae (PFB). » Use on all skin types (Fitzpatrick I-VI).

Source page: https://510kreport.com/device/K201594
Methodology: https://510kreport.com/methodology