# K073022: Clareblend Led Probes  Model# 7201-415, 7204-631, 7205-830

- Pathway: 510(k) (Traditional)
- Applicant: Clareblend, Inc.
- Decided: Oct 1, 2008 after 341 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
Longest line of descent: 9 generations back to K943450 (1995). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 1.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 1.
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 1.

## Indications for use
The Clareblend Probes are intended to provide light to the body. Clareblend Probe (Red-63 1) is generally indicated for the treatment of superficial, benign vascular and pigmented lesions Clareblend Probe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris. Clareblend Probe (IR-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Source page: https://510kreport.com/device/K073022
Methodology: https://510kreport.com/methodology