# K041262: Duralite-GL

- Pathway: 510(k) (Traditional)
- Applicant: Laser Scientific
- Decided: Aug 13, 2004 after 94 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: 6 generations back to K963094 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024371: Candela Gentle Lase Family of Laser System, Candela Corp. (2003) Summary page 1.
- K024260: Candela Gentlelase Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K024335: Candela Gentlelase Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K994260: Candela Gentlelase GL Dermatological Laser, Candela Corp. (2000) Summary page 1.
- K003460: Palomar Clear Light ND: Yag Laser System, Palomar Medical Technologies, Inc. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K984606: GentleLASE Plus Fiber Optic. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The DuraLite-GL Is a mplacement fiber optic component for the Candela GeirnleLASE family of lasers. The DuraLltsGL may be used as a replacement part for all procedures as cleared by the FDA for the Candela GentleLase family of lasers.

Source page: https://510kreport.com/device/K041262
Methodology: https://510kreport.com/methodology