# K120460: Smartlux

- Pathway: 510(k) (Traditional)
- Applicant: Medmix Co., Ltd.
- Decided: Oct 1, 2012 after 229 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.
18 later devices descend from it; 2 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 1.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 2.
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 2.

## Most influential descendants
- K190938: Phototherapy System (2019), 16 descendants of its own
- K222751: LED Light Therapy Device, KN-7000L (2023), 11 descendants of its own
- K241293: LED Light Therapy Device, ELIXIR MD™ (2024), 7 descendants of its own
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K200659: Dermalux Tri-Wave MD (2020), 3 descendants of its own

## Indications for use
633nm wave length :Dermatology for treatment of superficial, benign vascular, and pigmented lesions 415nm wave length Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris 830nm wave length 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/K120460
Methodology: https://510kreport.com/methodology