Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rhein Laser Technologies Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 | 55 | 0 |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) | Rhein Laser Technologies Co., Ltd. | 2024-11-19 | 109 | 0 |
| K233757 | TitanPico Laser Workstation (PICO-450) | Rhein Laser Technologies Co., Ltd. | 2024-04-11 | 139 | 0 |
| K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S2 | Rhein Laser Technologies Co., Ltd. | 2024-02-02 | 70 | 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