The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Dermatherm 100.
| Device ID | K980607 |
| 510k Number | K980607 |
| Device Name: | DERMATHERM 100 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | NEW STAR LASERS, INC. 11802 KEMPER RD. Auburn, CA 95603 |
| Contact | Nina Davis |
| Correspondent | Nina Davis NEW STAR LASERS, INC. 11802 KEMPER RD. Auburn, CA 95603 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-04-03 |
| Summary: | summary |