The following data is part of a premarket notification filed by Reliant Technologies, Inc. with the FDA for Acutome 100 Color-corrected Co2 Laser Handpiece.
| Device ID | K942935 |
| 510k Number | K942935 |
| Device Name: | ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RELIANT TECHNOLOGIES, INC. 1153 TRITON DRIVE, SUITE C Foster City, CA 94404 |
| Contact | Svetlana Black |
| Correspondent | Svetlana Black RELIANT TECHNOLOGIES, INC. 1153 TRITON DRIVE, SUITE C Foster City, CA 94404 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-22 |
| Decision Date | 1994-12-19 |