The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Surelase Co2 Laser System.
| Device ID | K121580 |
| 510k Number | K121580 |
| Device Name: | SURELASE CO2 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLINICON CORP. 1107 259TH ST NW Stanwood, WA 98292 -4834 |
| Contact | Gerald Palecki |
| Correspondent | Gerald Palecki CLINICON CORP. 1107 259TH ST NW Stanwood, WA 98292 -4834 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-30 |
| Decision Date | 2012-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850013050215 | K121580 | 000 |
| 00850013050208 | K121580 | 000 |