# K022583: FLASH 1

- Pathway: 510(k) (Traditional)
- Applicant: Emed, Inc.
- Decided: Oct 31, 2002 after 87 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
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EsteLux: named in the summary without a submission number
- (no number) ProLite Pulsed Light Systems: named in the summary without a submission number
- (no number) Spa Touch: named in the summary without a submission number
- (no number) IPL Quantum SR: named in the summary without a submission number

## Most influential descendants
- K051508: Med Flash II Intense Pulsed Light System. (2005), 8 descendants of its own
- K072331: Radiancy Mistral Device (2008), 6 descendants of its own
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own
- K181868: SHINY RPL System (2018), 1 descendant of its own

## Indications for use
This product is intended for dennatological use by physicians for the following: Removal of unwanted hair in all skin types Treatment of vascular and benign pigmented lesions

Source page: https://510kreport.com/device/K022583
Methodology: https://510kreport.com/methodology