The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Versapulse(tm) Twopointone/xe Holmium Surg Lasers.
| Device ID | K914991 |
| 510k Number | K914991 |
| Device Name: | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-07 |
| Decision Date | 1992-05-06 |