# K060792: Illumimed

- Pathway: 510(k) (Traditional)
- Applicant: Photoactif, LLC
- Decided: Dec 1, 2006 after 253 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943450 (1995). 130 ancestors in all.
115 later devices descend from it; 5 cite it directly.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050216: Omnilux Revive and Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 1.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 1.
- K042630: Revlight Skin Care System, Skincare Technology, Inc. (2005) Summary page 1.
- K041103: Acnelift, Inner Act, LLC (2004) Summary page 1.
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 1.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 8.

## Most influential descendants
- K083183: Aklarus Phototherapy System (2009), 91 descendants of its own
- K111286: Quasar Calypso (2012), 76 descendants of its own
- K162098: LED Phototherapy Device (2017), 75 descendants of its own
- K122237: Biophotas Lifelight (2013), 71 descendants of its own
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own

## Indications for use
Use of 430 ±10 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. Use of the 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs are indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 blood circulation. Use of the accessory "38 blue LED Wand", 430 ±10 nm "blue", is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. Use of the accessory "38 red/near infrared LED Wand", 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 blood circulation. Use of the accessory "240 red/near infrared LED Pad", 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 blood circulation.

Source page: https://510kreport.com/device/K060792
Methodology: https://510kreport.com/methodology