The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Laser-35.
| Device ID | K910200 |
| 510k Number | K910200 |
| Device Name: | LASER-35 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ENDO TECHNIC CORP. 3002 DOW AVENUE, STE 114 Tustin, CA 92680 |
| Contact | Philippe C Levy |
| Correspondent | Philippe C Levy ENDO TECHNIC CORP. 3002 DOW AVENUE, STE 114 Tustin, CA 92680 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-05-09 |