# K974460: Lite Touch Erbium Laser Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Lorad Corp.
- Decided: Jan 16, 1998 after 52 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: 2 generations back to K954013 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 2.
- K952554: Schwartz Electro-Optics, Inc. Trilase Laser System, Schwartz Electro-Optics, Inc. (1995) Summary page 2.
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 2.
- K970934: CB Erbium/2.94(TM) ER:Yag Laser, Continuum Biomedical, Inc. (1997). Our OCR of the scanned summary read K970394, FDA’s number for Osteonics Normalized AD-HA Acetabular Component System (Osteonics Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Continuum Biomedical, Inc. CB Erbium 2.94™ Er:YAG Laser System”.

## Indications for use
The Lite Touch Erbium Laser System is intended for the coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing

Source page: https://510kreport.com/device/K974460
Methodology: https://510kreport.com/methodology