Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laseroptek Co., Ltd. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
247 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | 2025-02-07 | 60 | 0 |
| K230373 | HELIOS 785 Pico | Laseroptek Co., Ltd. | 2023-05-22 | 98 | 0 |
| K223588 | PALLAS Premium | Laseroptek Co., Ltd. | 2023-01-26 | 56 | 0 |
| K212663 | HELIOS IV 785 | Laseroptek Co., Ltd. | 2022-06-09 | 290 | 0 |
| K212573 | PicoLO Premium | Laseroptek Co., Ltd. | 2021-12-08 | 114 | 0 |
| K203491 | PicoLO Nd: YAG Picosecond Laser System | Laseroptek Co., Ltd. | 2021-04-07 | 131 | 0 |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2020-01-03 | 211 | 0 |
| K183392 | PicoLO Nd:YAG Picosecond Laser System | Laseroptek Co., Ltd. | 2019-01-04 | 28 | 0 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | Laseroptek Co., Ltd. | 2018-12-27 | 150 | 0 |
| K172639 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2017-11-03 | 63 | 0 |
| K152856 | Helios III | Laseroptek Co., Ltd. | 2016-06-02 | 247 | 0 |
| K083253 | LOTUS II PULSED ER: YAG LASER SYSTEM | Laseroptek Co., Ltd. | 2009-05-15 | 192 | 0 |
| K083203 | HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM | Laseroptek Co., Ltd. | 2009-04-28 | 180 | 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