# K232236: Echo

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Oct 20, 2023 after 85 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: 22 generations back to K943450 (1995). 523 ancestors in all.
No later device cites it as a predicate yet.
0 of 524 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192483: MeDioStar, Asclepion Laser Technologies GmbH (2020) Summary page 5.
- K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity, Lumenis, Ltd. (2017) Summary page 5.

## Indications for use
The device is intended to be used in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology, including: - Treatment of benign vascular lesions - Hair removal - Permanent* hair reduction * permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.

Source page: https://510kreport.com/device/K232236
Methodology: https://510kreport.com/methodology