The following data is part of a premarket notification filed by Innotech Usa, Inc. with the FDA for The Friendlylight Nd: Yag Lasers.
| Device ID | K033251 |
| 510k Number | K033251 |
| Device Name: | THE FRIENDLYLIGHT ND: YAG LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INNOTECH USA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, Dc, DC |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein INNOTECH USA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, Dc, DC |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-07 |
| Decision Date | 2004-03-02 |
| Summary: | summary |