The following data is part of a premarket notification filed by Radiancy (israel) Ltd. with the FDA for Radiancy Acne System With Cleartouch Light Unit Assembly.
| Device ID | K032205 |
| 510k Number | K032205 |
| Device Name: | RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RADIANCY (ISRAEL) LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahn |
| Correspondent | Jonathan S Kahn RADIANCY (ISRAEL) LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-18 |
| Decision Date | 2003-12-11 |
| Summary: | summary |