Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Laseroptek with 13 510(k) clearances. The most recent is a 510(k) clearance dated Feb 7, 2025: HELIOS 785 Pico (1754V2).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Feb 7, 2025 | HELIOS 785 Pico (1754V2)K243780 · GEX | 510(k) clearances |
| May 22, 2023 | HELIOS 785 PicoK230373 · GEX | 510(k) clearances |
| Jan 26, 2023 | PALLAS PremiumK223588 · GEX | 510(k) clearances |
| Jun 9, 2022 | HELIOS IV 785K212663 · GEX | 510(k) clearances |
| Dec 8, 2021 | PicoLO PremiumK212573 · GEX | 510(k) clearances |
| Apr 7, 2021 | PicoLO Nd: YAG Picosecond Laser SystemK203491 · GEX | 510(k) clearances |
| Jan 3, 2020 | PALLAS 308/311 Solid-State UV Laser SystemK191501 · GEX | 510(k) clearances |
| Jan 4, 2019 | PicoLO Nd:YAG Picosecond Laser SystemK183392 · GEX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
