# K021762: Bclear

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Aug 23, 2002 after 86 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
Longest line of descent: 3 generations back to K885026 (1989). 9 ancestors in all.
750 later devices descend from it; 5 cite it directly.
0 of 760 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011197: Dermaclear UV-B Phototherapy System, Lumenis (2001)
- K020591: Bclear, Lumenis (2002) Summary page 1.
- K011382: Xtrac Excimer Laser System, Model AL 7000, Photo Medex, Inc. (2001)
- K992914: Excimer Laser Phototherapy System, AL7000, Acculase, Inc. (2000) Summary page 1.
- K003705: Xtrac Excimer Laser System, Model AL7000, Photo Medex, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K050796: Aurora DS, DS Applicator (2005), 301 descendants of its own

## Indications for use
The BClear, Targeted PhotoClearing System, is a medical ultraviolet lamp and delivery device intended for the treatment of leukoderma. The BClear, Targeted PhotoClearing System, is also indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. The BClear, Targeted Photoclearing System, is intended for use on all skin types (I - VI).

Source page: https://510kreport.com/device/K021762
Methodology: https://510kreport.com/methodology