# K183708: Poly Clear

- Pathway: 510(k) (Traditional)
- Applicant: Medtek Skincare, LLC
- Decided: Sep 17, 2019 after 260 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: 13 generations back to K943450 (1995). 100 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081307: Omnilux Clear-U, Photo Therapeutics, Inc. (2009) Summary page 4.
- K180900: LED Light Therapy Device, Uvbiotek, LLC (2018) Summary page 4.

## Most influential descendants
- K203214: DemarkQ WOW, DemarkQ POP (2021), 21 descendants of its own
- K230720: LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 (2023), 18 descendants of its own
- K240089: Face Patches (MT-12MA, MT-12MC) (2024), 16 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
- K242593: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (2025), 3 descendants of its own

## Indications for use
The Poly Clear combination of Red (633nm±10nm) and Blue (417nm±10nm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Source page: https://510kreport.com/device/K183708
Methodology: https://510kreport.com/methodology