The following data is part of a premarket notification filed by Solitec Gmbh with the FDA for Dermalight Psoracomb.
| Device ID | K903660 |
| 510k Number | K903660 |
| Device Name: | DERMALIGHT PSORACOMB |
| Classification | Lamp, Infrared, Non Heating |
| Applicant | SOLITEC GMBH FRAUNHOFERSTRASSE 5 Planegg, DE D-82152 |
| Contact | Schimd |
| Correspondent | Schimd SOLITEC GMBH FRAUNHOFERSTRASSE 5 Planegg, DE D-82152 |
| Product Code | IOB |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-10 |
| Decision Date | 1991-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816878020817 | K903660 | 000 |
| 00816878020794 | K903660 | 000 |
| 00816878020183 | K903660 | 000 |
| 00816878020176 | K903660 | 000 |
| 00816878020169 | K903660 | 000 |
| 00816878020152 | K903660 | 000 |
| 00816878020145 | K903660 | 000 |
| 00816878020138 | K903660 | 000 |