The following data is part of a premarket notification filed by Teknomed, Inc. with the FDA for Multilase 2100 C, 2100 D.
| Device ID | K913917 |
| 510k Number | K913917 |
| Device Name: | MULTILASE 2100 C, 2100 D |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TEKNOMED, INC. NORTH WOODS BUSINESS PARK 99 ROSEWOOD DRIVE, SUITE 140 Danvers, MA 01923 |
| Contact | Jean-luc Boulnois |
| Correspondent | Jean-luc Boulnois TEKNOMED, INC. NORTH WOODS BUSINESS PARK 99 ROSEWOOD DRIVE, SUITE 140 Danvers, MA 01923 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-03 |
| Decision Date | 1992-11-05 |