The following data is part of a premarket notification filed by Sciton, Inc. with the FDA for Contour Profile Laser.
| Device ID | K010285 |
| 510k Number | K010285 |
| Device Name: | CONTOUR PROFILE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SCITON, INC. 845 COMMERCIAL AVE. Palo Alto, CA 94303 |
| Contact | Peter N Allen |
| Correspondent | Peter N Allen SCITON, INC. 845 COMMERCIAL AVE. Palo Alto, CA 94303 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-31 |
| Decision Date | 2001-03-01 |