# K041242: Candela Smoothbeam Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Nov 22, 2004 after 195 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: 4 generations back to K002421 (2000). 5 ancestors in all.
229 later devices descend from it; 5 cite it directly.
0 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013825: Candela Smoothbeam Laser System, Candela Corp. (2002) Summary page 1.
- K030834: Candela Smoothbeam Laser System, Candela Corp. (2003) Summary page 1.

## Most influential descendants
- K053047: Fraxel SR Laser System (2006), 205 descendants of its own
- K063038: Fraxel Iii SR Laser System and Accessories (2007), 195 descendants of its own
- K071051: Fraxel Iii SR Laser System and Accessories (2007), 194 descendants of its own
- K080915: Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories (2008), 187 descendants of its own
- K083900: Erbium Fractional Handpiece (2009), 158 descendants of its own

## Indications for use
The Candela Smoothbeam Laser is indicated for the following uses: For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris New indication: Treatment of Sebaceous Hyperplasia

Source page: https://510kreport.com/device/K041242
Methodology: https://510kreport.com/methodology