The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Cutera Tabletop Aesthetic Product.
| Device ID | K042165 |
| 510k Number | K042165 |
| Device Name: | CUTERA TABLETOP AESTHETIC PRODUCT |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CUTERA, INC. 3240 BAYSHORE BLVD. Brisbane, CA 94005 |
| Contact | Kathy Maynor |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-11 |
| Decision Date | 2004-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816722021915 | K042165 | 000 |