# K192620: SNA-001 Silver Photoparticle Topical Gel

- Pathway: 510(k) (Traditional)
- Applicant: Sienna Biopharmaceuticals, Inc.
- Decided: Aug 12, 2020 after 324 days
- Product code: QCY (Laser Absorbing Particles)
- 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: 1 generation back to K971207 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971207: Softlight Q-Switched (ND:Yag) Laser, Thermolase Corp. (1998) Summary page 4.

## Indications for use
SNA-001 Silver Photoparticle Topical Gel is indicated for use as an accessory to 810 nm diode laser for temporary removal of light-colored hair in patients with skin types I, II and III. Light-colored hair types include blonde, light red, light brown, gray and white.

Source page: https://510kreport.com/device/K192620
Methodology: https://510kreport.com/methodology