# K041994: Multiclear XL Multiwavelength Targeted Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Curelight, Ltd.
- Decided: Oct 6, 2004 after 75 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) MultiClear Multiwavelength Targeted Phototherapy System: named in the summary without a submission number
- (no number) ClearLight: named in the summary without a submission number
- (no number) ClearTouch Acne Therapy System: named in the summary without a submission number

## Indications for use
The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K041994
Methodology: https://510kreport.com/methodology