# K014128: Candela Smoothbeam Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Oct 4, 2002 after 291 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: 1 generation back to K002421 (2000). 1 ancestor in all.
527 later devices descend from it; 4 cite it directly.
0 of 529 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002421: Candela Mid IR Diode Laser System, Candela Corp. (2000) Summary page 1.

## Most influential descendants
- K030453: Cooltouch ND: Yag Laser System (2003), 524 descendants of its own
- K032459: Profile 1320 Laser System (2004), 518 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
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own

## Indications for use
The Candela Smoothbeam Laser System is indicated for use for the treatment of back acne.

Source page: https://510kreport.com/device/K014128
Methodology: https://510kreport.com/methodology