# K140837: Lucid LY

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med USA, Inc.
- Decided: Sep 24, 2014 after 175 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: 13 generations back to K910422 (1992). 129 ancestors in all.
No later device cites it as a predicate yet.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113588: Spectra Laser System, Lutronic Corporation (2012) Summary page 4.

## Indications for use
LUCID LY, the laser system is indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064nm Wavelength: Tattoo removal: dark ink (black, blue and brown) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi, Melasma Skin resurfacing procedures for the treatment of acne scars and wrinkle

Source page: https://510kreport.com/device/K140837
Methodology: https://510kreport.com/methodology