The following data is part of a premarket notification filed by Innotech Usa, Inc. with the FDA for Friendly Light Er:yag Pulsed Laser.
| Device ID | K000023 |
| 510k Number | K000023 |
| Device Name: | FRIENDLY LIGHT ER:YAG PULSED LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INNOTECH USA, INC. 116 VILLAGE BLVD. SUITE 200 Princeton, NJ 08540 -5799 |
| Contact | Thomas Becze |
| Correspondent | Thomas Becze INNOTECH USA, INC. 116 VILLAGE BLVD. SUITE 200 Princeton, NJ 08540 -5799 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-04 |
| Decision Date | 2000-11-06 |