The following data is part of a premarket notification filed by Leana Orders, Inc. with the FDA for Grivamax Hair Growth System.
| Device ID | K171895 |
| 510k Number | K171895 |
| Device Name: | Grivamax Hair Growth System |
| Classification | Laser, Comb, Hair |
| Applicant | Leana Orders, Inc. 431 Travis Avenue Staten Island, NY 10314 -6150 |
| Contact | Leonid Krits |
| Correspondent | Raymond R. Blanche NST Consulting, LLC 641 Shunpike Road 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 | 2017-06-26 |
| Decision Date | 2017-08-22 |
| Summary: | summary |