510(k) · Cleared
ClearedSNA-001 Silver Photoparticle Topical Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sienna Biopharmaceuticals, Inc. · QCY Laser Absorbing Particles
Cleared on Aug 12, 2020 as substantially equivalent to K971207 (Thermolase Corp., 1998) after a 324-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Aug 12, 2020
- Review
- 324 days
- Class
- Class II
- Product code
- QCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971207 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK971207 Softlight Q-Switched (ND:Yag) LaserThermolase Corp. · 1998
- This deviceK192620 SNA-001 Silver Photoparticle Topical GelSienna Biopharmaceuticals, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971207 | Softlight Q-Switched (ND:Yag) Laser | Thermolase Corp. | 1998 | — |
| 0 (this device) | K192620 | SNA-001 Silver Photoparticle Topical Gel | Sienna Biopharmaceuticals, Inc. | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QCY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971207 | Softlight Q-Switched (ND:Yag) LaserSummary page 4…Regulation No.: 878.4810 Product Code: QCY Prior Product Code: GEX Predicate Device: ThermoLase® Softlight Carbon Lotion (K971207) Device Description: SNA-001 Silver Photoparticle Topical Gel (SNA-001) is used as an accessory to 810 nm diode dermatologic la… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K971207.
How does its category compare?
All QCY devicesQCY Laser Absorbing Particles: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QCY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QCY
Too few QCY 510(k)s in any year since 2007 to give a median.
Recalls per year · QCY
No recall names QCY since 2007.
Adverse event reports per year · QCY
No MAUDE report names QCY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192620: SNA-001 Silver Photoparticle Topical Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192620
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026