# Hair International Systems USA, Inc.

- Location (FDA's records): Newport Beach, CA
- FDA decisions: 1 (2006–2006): 1 510(k) clearance
- Product codes: GEX (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Novalis Medical, LLC: 1 (https://510kreport.com/company/novalis-medical)
- Medical Bio Care Sweden AB: 1 (https://510kreport.com/company/medical-bio-care-sweden)
- Emed, Inc.: 1 (https://510kreport.com/company/emed)
- Esc Medical Systems, Ltd.: 1 (https://510kreport.com/company/esc-medical-systems)

## Recent decisions
- K052371: Depilite EL-8B Series Dermo Flash Systems (May 4, 2006)

Source page: https://510kreport.com/company/hair-international-systems-usa