The following data is part of a premarket notification filed by Epulse Technologies, Inc. with the FDA for Epulse Model 2940 Er:aser Er:yag Laser System.
| Device ID | K973576 |
| 510k Number | K973576 |
| Device Name: | EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EPULSE TECHNOLOGIES, INC. 4838 BENTREE AVE. Long Beach, CA 90807 -1007 |
| Contact | Sanford Damasco |
| Correspondent | Sanford Damasco EPULSE TECHNOLOGIES, INC. 4838 BENTREE AVE. Long Beach, CA 90807 -1007 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1997-12-09 |
| Summary: | summary |