Poly Clear— 510(k) K183708

Name: FDA 510(k) clearance K183708
Creator: U.S. Food and Drug Administration
Published: 2019-09-17

Substantially Equivalent

Medtek Skincare, LLC

FDA 510(k) clearance K183708 for Poly Clear, Substantially Equivalent on 2019-09-17. Applicant: Medtek Skincare, LLC. Device class: 2.

Clearance details

Applicant: Medtek Skincare, LLC
Product code: Code OLP
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2018-12-31
Decision date: 2019-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLP

view all

K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)2026-03-04
K251843 — Erchonia EVRL2025-09-12
K242068 — LED Light Therapy Mask (RT01)2025-04-04
K243555 — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)2025-02-05
K232656 — BLU TOTALE (Model: ENEOB852)2023-11-14

More clearances from Medtek Skincare, LLC

view all

K180875 — POLY REJUV2018-09-14

Adverse events under product code OLP

product code OLP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.