# K013825: Candela Smoothbeam Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Feb 15, 2002 after 88 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: 1 generation back to K002421 (2000). 2 ancestors in all.
740 later devices descend from it; 5 cite it directly.
0 of 743 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003715: Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch, Cooltouch II, Cooltouch Corp. (2001) Summary page 1.
- K002421: Candela Mid IR Diode Laser System, Candela Corp. (2000) Summary page 1.

## Most influential descendants
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022884: Candela Smoothbeam Laser System (2003), 642 descendants of its own
- K030834: Candela Smoothbeam Laser System (2003), 603 descendants of its own
- K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System (2004), 569 descendants of its own
- K030453: Cooltouch ND: Yag Laser System (2003), 524 descendants of its own

## Recalls of this device
- Nov 25, 2003 · Not classified · Z-0291-04: Laser may pulse and not dispense cryogen resulting in patient injury

## Indications for use
The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles. The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment

Source page: https://510kreport.com/device/K013825
Methodology: https://510kreport.com/methodology