The following data is part of a premarket notification filed by Radiancy (israel) Ltd. with the FDA for Radiancy Skinstation With Psoriasis Light Unit Assembly.
| Device ID | K052442 |
| 510k Number | K052442 |
| Device Name: | RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RADIANCY (ISRAEL) LTD. 40 RAMLAND ROAD SUITE 10 Orangeburg, NY 10962 |
| Contact | Margaret R Fourte |
| Correspondent | Margaret R Fourte RADIANCY (ISRAEL) LTD. 40 RAMLAND ROAD SUITE 10 Orangeburg, NY 10962 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2006-01-26 |
| Summary: | summary |