# K951033: Andela Dynamic Cooling Device

- Pathway: 510(k) (Traditional)
- Applicant: Candela Laser Corp.
- Decided: Aug 15, 1996 after 528 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,265 later devices descend from it; 5 cite it directly.
0 of 1,266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cool Laser Optics Device: named in the summary without a submission number
- (no number) Cold Packs: named in the summary without a submission number

## Most influential descendants
- K000944: Thermage Thermacool System (2000), 1,069 descendants of its own
- K001589: Candela Dynamic Cooling Device (2000), 1,064 descendants of its own
- K990417: Dermacool (1999), 1,062 descendants of its own
- 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

## Indications for use
The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.

Source page: https://510kreport.com/device/K951033
Methodology: https://510kreport.com/methodology