The following data is part of a premarket notification filed by Apira Science, Inc. with the FDA for Igrow Ii Hair Growth System.
| Device ID | K122248 |
| 510k Number | K122248 |
| Device Name: | IGROW II HAIR GROWTH SYSTEM |
| Classification | Laser, Comb, Hair |
| Applicant | APIRA SCIENCE, INC. 641 SHUNPIKE RD, STE 311 Chatham, NJ 07928 |
| Contact | Raymond R Blanche |
| Correspondent | Raymond R Blanche APIRA SCIENCE, INC. 641 SHUNPIKE RD, STE 311 Chatham, NJ 07928 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-27 |
| Decision Date | 2012-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20861134000106 | K122248 | 000 |