The following data is part of a premarket notification filed by Hair International Systems Usa, Inc. with the FDA for Depilite El-8b Series Dermo Flash Systems.
| Device ID | K052371 |
| 510k Number | K052371 |
| Device Name: | DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HAIR INTERNATIONAL SYSTEMS USA, INC. 4590 MACARTHER BLVD., STE. 500 Newport Beach, CA 92692 -2028 |
| Contact | Craig A Mitchell |
| Correspondent | Craig A Mitchell HAIR INTERNATIONAL SYSTEMS USA, INC. 4590 MACARTHER BLVD., STE. 500 Newport Beach, CA 92692 -2028 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-30 |
| Decision Date | 2006-05-04 |
| Summary: | summary |