The following data is part of a premarket notification filed by Apira Science, Inc. with the FDA for Igrow - Ii Hair Growth System, Igrow Hair Growth System.
| Device ID | K141567 |
| 510k Number | K141567 |
| Device Name: | IGROW - II HAIR GROWTH SYSTEM, IGROW 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 | 2014-06-12 |
| Decision Date | 2014-08-21 |
| Summary: | summary |