The following data is part of a premarket notification filed by Radiancy (israel) Ltd. with the FDA for No!no! Skin.
| Device ID | K102477 |
| 510k Number | K102477 |
| Device Name: | NO!NO! SKIN |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | RADIANCY (ISRAEL) LTD. 5 HANAGAR STREET Hod Hasharon, IL 45240 |
| Contact | Rothman Julia |
| Correspondent | Rothman Julia RADIANCY (ISRAEL) LTD. 5 HANAGAR STREET Hod Hasharon, IL 45240 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-30 |
| Decision Date | 2010-10-04 |
| Summary: | summary |