# K001589: Candela Dynamic Cooling Device

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Aug 18, 2000 after 87 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: 3 generations back to K904627 (1991). 21 ancestors in all.
1,064 later devices descend from it; 4 cite it directly.
0 of 1,086 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951033: Andela Dynamic Cooling Device, Candela Laser Corp. (1996) Summary page 1.
- K972347: Modified Coherent Versapulse Aesthetic Surgical Laser, Lumenis, Inc. (1997) Summary page 1.

## Most influential descendants
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 descendants of its own
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems (2003), 856 descendants of its own
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems (2003), 756 descendants of its own
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems (2003), 756 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own

## Indications for use
The intended use of the Candela Dynamic Cooling Device is: (1) cooling of the skin prior to laser treatment (2) reduction of pain during laser treatment (3) allows for use of higher laser fluences for laser treatments, such as for hair removal and vascular lesions (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions

Source page: https://510kreport.com/device/K001589
Methodology: https://510kreport.com/methodology