Laseroptek
Seongnam Gyeonggi, KR
LASEROPTEK appears in FDA device records in Seongnam Gyeonggi, KR. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Laseroptek between 2009 and 2025. The busiest year on record is 2009, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243780 | HELIOS 785 Pico (1754V2) | GEX | Substantially Equivalent | |
| K230373 | HELIOS 785 Pico | GEX | Substantially Equivalent | |
| K223588 | PALLAS Premium | GEX | Substantially Equivalent | |
| K212663 | HELIOS IV 785 | GEX | Substantially Equivalent | |
| K212573 | PicoLO Premium | GEX | Substantially Equivalent | |
| K203491 | PicoLO Nd: YAG Picosecond Laser System | GEX | Substantially Equivalent | |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | GEX | Substantially Equivalent | |
| K183392 | PicoLO Nd:YAG Picosecond Laser System | GEX | Substantially Equivalent | |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | GEX | Substantially Equivalent | |
| K172639 | PALLAS 308/311 Solid-State UV Laser System | GEX | Substantially Equivalent | |
| K152856 | Helios III | GEX | Substantially Equivalent | |
| K083253 | LOTUS II PULSED ER: YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K083203 | HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007181527 | 3007181527 | LASEROPTEK | Hyundai I valley 114,116,117,203,204 and 215 31, Galmachi-ro, Seongnam Gyeonggi 13212 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain