# K030834: Candela Smoothbeam Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Dec 3, 2003 after 261 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: 3 generations back to K002421 (2000). 4 ancestors in all.
603 later devices descend from it; 2 cite it directly.
0 of 608 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022884: Candela Smoothbeam Laser System, Candela Corp. (2003) Summary page 1.

## Most influential descendants
- K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System (2004), 569 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K041242: Candela Smoothbeam Laser System (2004), 229 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 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 the treatment of mild to moderate inflammatory acne vulgaris. 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/K030834
Methodology: https://510kreport.com/methodology