# K051359: Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jul 13, 2005 after 50 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K910422 (1992). 166 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B, Candela Corp. (2005) Summary page 1.
- K042000: Modified MSQ Family of Lovely Light/Laser Systems, Msq (M2), Ltd. (2004). Our reading of the summary gave K040200, FDA’s number for Mesacup-2 Test Cenp-B (Rhigene, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “MSQ Family of Laser/Light System Handpieces”.

## Cited in the summary but kept off the family tree
- K011746: MB 11, Maico Diagnostic GmbH (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K060977: Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523 (2006), 0 descendants of its own

## Recalls of this device
- Jan 17, 2006 · Not classified · Z-0842-06: Handle fires even when the finger is off the switch

## Indications for use
The Candela Family of Pulse Dye Laser Systems Pigmented Lesion Handpiece Accessory is indicated for the Treatment of Benign Epidermal Pigmented Lesions

Source page: https://510kreport.com/device/K051359
Methodology: https://510kreport.com/methodology