The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Family Of Square Epil (alex, Alex2, Nd:yag, Alex+nd:yag).
| Device ID | K161632 |
| 510k Number | K161632 |
| Device Name: | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOS S.R.L. VIA GUIDO ROSSA, 10/12 Vimodrone, IT I-20090 |
| Contact | Riccardo Pisati |
| Correspondent | Riccardo Pisati BIOS S.R.L. VIA GUIDO ROSSA, 10/12 Vimodrone, IT I-20090 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2016-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052049500067 | K161632 | 000 |
| 08052049500029 | K161632 | 000 |