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 |