FDA Device Establishments · JSON-LD · Markdown
FEI 3007181527 · Manufacture Medical Device · Status: Active
| FEI Number | 3007181527 |
|---|---|
| Owner / Operator | Laseroptek Co., Ltd. (#10029810) |
| Address | Hyundai I valley 114,116,117,203,204 and 215 31, Galmachi-ro, 244beon-gil, Jungwon-gu,, Seongnam Gyeonggi, 13212, KR |
| Mandatory US Agent | BT Solutions USA, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GEX |
| Regulation § (21 CFR) | 878.4810 |
| Proprietary names | HYPERION Long Pulsed Nd:YAG Dermatological Laser |
Source: openFDA. Public-domain (CC0).