# K060977: Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523

- Pathway: 510(k) (Traditional)
- Applicant: Hoya Conbio, Inc.
- Decided: May 24, 2006 after 44 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: 10 generations back to K910422 (1992). 167 ancestors in all.
No later device cites it as a predicate yet.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051359: Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory, Candela Corp. (2005) Summary page 1.
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 1.

## Indications for use
Tattoo Removal Nevus of Ota Hair Removal Vascular Lesions Dermal Pigmented Lesions Epidermal Pigmented Lesions Laser Resurfacing for Acne scars and wrinkles Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Source page: https://510kreport.com/device/K060977
Methodology: https://510kreport.com/methodology