# K052371: Depilite EL-8B Series Dermo Flash Systems

- Pathway: 510(k) (Traditional)
- Applicant: Hair International Systems USA, Inc.
- Decided: May 4, 2006 after 247 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910422 (1992). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043319: Clareon and Solarus Pulsed Light Devices and Accessories, Novalis Medical, LLC (2004) Summary page 2.
- K023081: Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction), Medical Bio Care Sweden AB (2002) Summary page 2.
- K022583: FLASH 1, Emed, Inc. (2002) Summary page 2.
- K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 2.

## Indications for use
The Depilite EL-8b DERMO FLASH™ Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. The Depilite EL-8b DERMO FLASH™ Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. The Depilite EL-8b DERMO FLASH™ Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne. The Depilite EL-8b DERMO FLASH™ Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.

Source page: https://510kreport.com/device/K052371
Methodology: https://510kreport.com/methodology