The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Cutera Optional Pulsed Light Hand Piece Family.
| Device ID | K050047 |
| 510k Number | K050047 |
| Device Name: | CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CUTERA, INC. 3240 BAYSHORE BLVD. Brisbane, CA 94005 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor CUTERA, INC. 3240 BAYSHORE BLVD. Brisbane, CA 94005 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-10 |
| Decision Date | 2005-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816722022172 | K050047 | 000 |
| 00816722022165 | K050047 | 000 |
| 00816722022134 | K050047 | 000 |
| 00816722022127 | K050047 | 000 |
| 00816722022110 | K050047 | 000 |
| 00816722022103 | K050047 | 000 |
| 00816722022820 | K050047 | 000 |
| 00816722022813 | K050047 | 000 |
| 00816722022806 | K050047 | 000 |