Data / Medical devices / United States / Medtek Skin Care, Inc.

Medtek Skin Care, Inc.: FDA-registered device maker in Hudson Falls, NY, United States, 11 510(k) clearances

Name: Medtek Skin Care, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtek Skin Care, Inc. is registered with the FDA (registration 1318319) in Hudson Falls, NY, United States. It lists 5 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 14, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1318319
Address: 3 Depot St, Hudson Falls, NY, United States, 12839
Owner or operator: MEDTEK Skin Care, Inc. (1318319)
Roles: Complaint file establishment, Manufacturer
First device listed: May 6, 2008
Registered through: 2026
Brand names listed: Express Tan, Model 1600B, Model 2400B, Model 3200A, Model 800B, Models 3200B and 4000B, POLY Go, POLY Pro and more

Devices it lists

Device	Product code	Class	Role	Source
Booth, Sun Tan	LEJ	2	Manufacturer	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Complaint file establishment	accessdata.fda.gov
Light, Ultraviolet, Dermatological	FTC	2	Manufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 14, 2018	K180875	POLY REJUV	OHS	Substantially Equivalent	Medtek Skincare, LLC	accessdata.fda.gov
July 10, 2018	K180900	LED Light Therapy Device	OLP	Substantially Equivalent	Uvbiotek, LLC	accessdata.fda.gov
July 28, 2017	K170187	Photodynamic Therapy Device	GEX	Substantially Equivalent	Uvbiotek, LLC	accessdata.fda.gov
May 19, 2016	K152452	Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200	LEJ	Substantially Equivalent	Medtek Lighting Corp D/B/A Peacock Tanning	accessdata.fda.gov
October 15, 2014	K134009	UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL	FTC	Substantially Equivalent	Medtek Lighting	accessdata.fda.gov
May 25, 2012	K111049	MOBILE VERSA LIGHT	FTC	Substantially Equivalent	Medtek Lighting Corp	accessdata.fda.gov
November 18, 2005	K051330	UVBIOTEK MODELS 3200B AND 4000B	FTC	Substantially Equivalent	Medtek Lighting Corporation	accessdata.fda.gov
February 21, 1995	K933954	PHOTOTHERAPEUTIX MODEL 2400B	FTC	Substantially Equivalent	Avex Industries , Ltd.	accessdata.fda.gov
February 21, 1995	K933952	PHOTOTHERAPEUTIX MODEL 800B	FTC	Substantially Equivalent	Avex Industries , Ltd.	accessdata.fda.gov
February 17, 1995	K935526	PHOTOTHERAPEUTIX MODEL 1600B	FTC	Substantially Equivalent	Avex Industries , Ltd.	accessdata.fda.gov
February 17, 1995	K935524	PHOTOTHERAPEUTIX MODEL 3200A	FTC	Substantially Equivalent	Avex Industries , Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 14, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.