# K030846: Candela Smoothbeam Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Sep 16, 2003 after 183 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 K820106 (1982). 11 ancestors in all.
317 later devices descend from it; 1 cites it directly.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022817: Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model Cooltouch-II, Icn Pharmaceuticals, Inc. (2002) Summary page 1.
- K022884: Candela Smoothbeam Laser System, Candela Corp. (2003) Summary page 1.

## Most influential descendants
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own
- K061652: Palomar LUX1540 Handpiece (2007), 259 descendants of its own
- K060310: Fraxel II SR Laser System and Accessories (2006), 230 descendants of its own
- K062303: Fraxel II SR Laser System (2007), 226 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 the treatment of facial wrinkles.

Source page: https://510kreport.com/device/K030846
Methodology: https://510kreport.com/methodology