# K161434: Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)

- Pathway: 510(k) (Traditional)
- Applicant: Li-Tek Electronics Technologies
- Decided: Sep 28, 2017 after 492 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- 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: 12 generations back to K943450 (1995). 97 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132833: Ultra Renew Plus, Accord Media (2014) Summary page 5.
- K124042: Tanda Mini Skincare System, Syneron Beauty (2013) Summary page 5.
- K161941: Pulsaderm Acne Device, Nutra Luxe MD, LLC (2016). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K250761: KALA Therapy Wand (Model: KALA-03) (2025), 1 descendant of its own
- K252272: ORA Method LED Gua Sha (GS-04) (2025), 0 descendants of its own
- K251076: Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) (2025), 0 descendants of its own

## Indications for use
The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use. LED functional mode - To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face. - To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne. Vibrating massage functional mode As an electrically powered device intended for medical purposes to relieve minor aches and pains.

Source page: https://510kreport.com/device/K161434
Methodology: https://510kreport.com/methodology