The following data is part of a premarket notification filed by Care Electronics, Inc. with the FDA for Dermillume Red, Model Hr1000.
| Device ID | K051681 |
| 510k Number | K051681 |
| Device Name: | DERMILLUME RED, MODEL HR1000 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CARE ELECTRONICS, INC. 4700 STERLING DR., SUITE D Boulder, CO 80301 |
| Contact | Thomas O Moody |
| Correspondent | Thomas O Moody CARE ELECTRONICS, INC. 4700 STERLING DR., SUITE D Boulder, CO 80301 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-23 |
| Decision Date | 2005-07-27 |
| Summary: | summary |