Data / Medical devices / United States / Dermatech Innovations LLC

Dermatech Innovations LLC: FDA-registered device maker in Bal Harbour, FL, United States, 3 510(k) clearances

Name: Dermatech Innovations LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dermatech Innovations LLC is registered with the FDA (registration 3020900954) in Bal Harbour, FL, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3020900954
Address: 10275 Collins Ave Apt 615, Bal Harbour, FL, United States, 33154
Owner or operator: DERMATECH INNOVATIONS LLC (10095175)
Roles: Repackager or relabeler
First device listed: February 3, 2026
Registered through: 2026
Brand names listed: ; LED therapy mat; LED Light Therapy Device red light therapy panel Lamp, Infrared, Therapeutic Heating;, Beauty Eye Instrument D118, Hot & Cold Skin Care Device D829, DPL Skin Rejuvenation Beauty Instrument; LED Facial Mask; LED therapy light, Dermatech HIFU System, LED LIGHT THERAPY MASK; XZF-300 ,XZF-300-1, XZF-900, XZF-1500, XZF-1500pro, XZF-3000, XZF-5000, XFF-7000, SP-1103,, LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6), Laser, comb, hair, M03; XZF-THE01;XZF-THE02;XZF-THE03;XZF-THE04;XZF-THE05;XZF-THE06;XZF-THE07;XZF-THE08;XZF-THE09;XZF-THE10;XZF-THE11; and more

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Repackager or relabeler	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Repackager or relabeler	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Repackager or relabeler	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Repackager or relabeler	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	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
December 19, 2025	K253054	LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)	OHS	Substantially Equivalent	Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.	accessdata.fda.gov
October 24, 2023	K232356	Laser Cap, Model: Hat-01	OAP	Substantially Equivalent	Hubei Yjt Technology Co.,Ltd	accessdata.fda.gov
May 27, 2020	K200525	Medical Diode Laser Hair Removal System	GEX	Substantially Equivalent	Weifang Mingliang Electronics Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 19, 2025. 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.