# K083183: Aklarus Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Hill Laboratories Co.
- Decided: Jul 16, 2009 after 261 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: 11 generations back to K943450 (1995). 131 ancestors in all.
91 later devices descend from it; 4 cite it directly.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060792: Illumimed, Photoactif, LLC (2006) Summary page 2.
- K050216: Omnilux Revive and Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 2.
- K041103: Acnelift, Inner Act, LLC (2004) Summary page 2.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 3.
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 3.

## Most influential descendants
- K111286: Quasar Calypso (2012), 76 descendants of its own
- K162098: LED Phototherapy Device (2017), 75 descendants of its own
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own
- K152280: BioPhotas Celluma3 (2016), 49 descendants of its own
- K200983: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine (2021), 46 descendants of its own

## Indications for use
The Aklarus Blue (420nm +/-1Onm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Aklarus combination of Red (628nm +/-10rm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat. mild to moderate acne vulgaris. The Aklarus Anti-Aging Red (628nm +/-lOnm) and Anti-Aging Infrared (880nm +/-10nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. The Aklarus Infrared (880nm +/-1Onm) is intended to emit energy 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 local blood circulation where applied.

Source page: https://510kreport.com/device/K083183
Methodology: https://510kreport.com/methodology