# K191321: Primelase Excellence

- Pathway: 510(k) (Traditional)
- Applicant: High Technology Products S.L.U
- Decided: Aug 2, 2019 after 79 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: 22 generations back to K943450 (1995). 526 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 535 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform, Alma Lasers, Ltd. (2014) Summary page 4.
- K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity, Lumenis, Ltd. (2017) Summary page 4.
- K180719: InMode Diolaze System, Inmode MD, Ltd. (2018) Summary page 4.

## Most influential descendants
- K193367: elysion-pro (2020), 3 descendants of its own
- K201594: Primelase Excellence (2020), 2 descendants of its own
- K241656: Eneka Selectif (2024), 1 descendant of its own
- K214049: Leaseir MHR Xcell (2022), 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
Indications for use for PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators include: • 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/K191321
Methodology: https://510kreport.com/methodology