# K011197: Dermaclear UV-B Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis
- Decided: Dec 14, 2001 after 239 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
762 later devices descend from it; 3 cite it directly.
0 of 763 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021762: Bclear (2002), 750 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K042630: Revlight Skin Care System (2005), 402 descendants of its own
- K041969: Aurora DS (2004), 302 descendants of its own

Source page: https://510kreport.com/device/K011197
Methodology: https://510kreport.com/methodology