Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beijing Sano Laser S&T Development Co.,Ltd — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
257 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 | 93 | 0 |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) | Beijing Sano Laser S&T Development Co.,Ltd | 2025-06-12 | 76 | 0 |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | Beijing Sano Laser S&T Development Co.,Ltd | 2025-01-27 | 124 | 0 |
| K233416 | Cryojet Plus (SHE-ACP001-1) | Beijing Sano Laser S&T Development Co.,Ltd | 2024-02-06 | 119 | 0 |
| K230024 | HI-EMT MAGSHAPE | Beijing Sano Laser S&T Development Co.,Ltd | 2023-09-06 | 245 | 0 |
| K191970 | Diode Laser Hair Removal System | Beijing Sano Laser S&T Development Co.,Ltd | 2020-04-06 | 257 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda