Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Gsd Tech Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
252 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230060 | Light Based Hair Removal Device GP592 | Shenzhen Gsd Tech Co., Ltd. | 2023-03-03 | 53 | 0 |
| K213225 | Diode Laser System GP900A8, Diode Laser System GP900Q8 | Shenzhen Gsd Tech Co., Ltd. | 2021-12-22 | 84 | 0 |
| K202827 | 308nm Excimer UV-light Skin Therapy System | Shenzhen Gsd Tech Co., Ltd. | 2020-12-15 | 82 | 0 |
| K191518 | CO2 Laser System | Shenzhen Gsd Tech Co., Ltd. | 2019-09-12 | 97 | 0 |
| K180383 | Light based hair removal device | Shenzhen Gsd Tech Co., Ltd. | 2018-05-11 | 88 | 0 |
| K142186 | DIODE LASER HAIR REMOVAL SYSTEM | Shenzhen Gsd Tech Co., Ltd. | 2015-04-17 | 252 | 0 |
| K091664 | GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009-11-16 | 160 | 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