# K061341: Palmlight 10, Model 001-00030

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Jun 12, 2006 after 28 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Bluephase 16i: named in the summary without a submission number
- (no number) Palmlight (CAO Group, Inc.): named in the summary without a submission number
- (no number) Palmlight (Ultradent Products, Inc.): named in the summary without a submission number

## Most influential descendants
- K191865: SmartLite Pro Modular LED Curing Light (2019), 0 descendants of its own
- K150585: Ascent 3D (2015), 0 descendants of its own

## Indications for use
For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light.

Source page: https://510kreport.com/device/K061341
Methodology: https://510kreport.com/methodology