The following data is part of a premarket notification filed by Care Electronics, Inc. with the FDA for Dermillume, Model Pro1000.
| Device ID | K043575 |
| 510k Number | K043575 |
| Device Name: | DERMILLUME, MODEL PRO1000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARE ELECTRONICS, INC. 4700 STERLING DR., SUITE D Boulder, CO 80301 |
| Contact | Thomas Moody |
| Correspondent | Thomas Moody CARE ELECTRONICS, INC. 4700 STERLING DR., SUITE D Boulder, CO 80301 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-02-24 |
| Summary: | summary |