Plate VII · Filings

The gazetteer of regulatory clearances.

Name: Biohacker Atlas FDA Clearance Database
Creator: Biohacker Atlas
License: https://open.fda.gov/license/

Verified FDA filings for biohacking devices, sourced from the public openFDA 510(k) and PMA endpoints. Every entry links to the device record on accessdata.fda.gov so you can confirm the source.

21 verified entries How we classify →

Brand	Category	Type	K / PMA #	Decision	Device name
Flow Neuroscience (FL-100)	tDCS & Brain Stimulation	PMA	P230024	2025-12-08	Flow FL-100	FDA record →
CurrentBody Skin	Red Light Therapy	510(K)	K250966	2025-06-25	CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)	FDA record →
MyoLift (7E Wellness)	Anti-Aging Devices (Microcurrent/RF/LED)	510(K)	K213078	2023-04-27	Myolift QT	FDA record →
gammaCore Sapphire	Vagus Nerve Stimulators	510(K)	K211856	2021-09-10	gammaCore Sapphire	FDA record →
Sprynge / Wireless Wearable EMS (category filler: Therabody PowerDot Duo Pro)	EMS Muscle Stimulators	510(K)	K210938	2021-07-30	PowerDot PD-01MT2 Muscle Stimulator	FDA record →
BEMER	PEMF Mats & Devices	510(K)	K210174	2021-02-04	BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set	FDA record →
Compex Sport Elite 3.0	EMS Muscle Stimulators	510(K)	K201653	2020-11-27	Compex Sport Elite 3.0	FDA record →
FOREO (BEAR 2)	Anti-Aging Devices (Microcurrent/RF/LED)	510(K)	K200803	2020-07-31	BEAR and BEAR mini	FDA record →
TriPollar (Pollogen)	Anti-Aging Devices (Microcurrent/RF/LED)	510(K)	K182774	2019-06-19	STOP U (Packed Black USA), STOP U (Packed White USA)	FDA record →
Therabody PowerDot 2.0	EMS Muscle Stimulators	510(K)	K181759	2018-11-09	PowerDot PD-01MT	FDA record →
Dr. Dennis Gross (SpectraLite FaceWare Pro)	Anti-Aging Devices (Microcurrent/RF/LED)	510(K)	K171386	2017-08-07	dpl SpectraLite	FDA record →
ZIIP Beauty	Anti-Aging Devices (Microcurrent/RF/LED)	510(K)	K161484	2017-02-24	ZIIP Device	FDA record →
Slendertone Connect Abs	EMS Muscle Stimulators	510(K)	K161974	2016-11-01	SLENDERTONE® Connect Abs, Type 570	FDA record →
NEWA	Anti-Aging Devices (Microcurrent/RF/LED)	510(K)	DEN150005	2015-12-18	Newa Skin Therapy System	FDA record →
Marc Pro / Marc Pro Plus	EMS Muscle Stimulators	510(K)	K131910	2014-01-24	MPP	FDA record →
LightStim	Red Light Therapy	510(K)	K101190	2010-07-01	LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC	FDA record →
Omnilux	Anti-Aging Devices (Microcurrent/RF/LED)	510(K)	K072459	2008-03-03	OMNILUX NEW-U	FDA record →
Summit to Sea	Hyperbaric Oxygen Chambers	510(K)	K072757	2008-02-08	DIVE AND SHALLOW AND GRAND DIVE	FDA record →
NuFACE	Anti-Aging Devices (Microcurrent/RF/LED)	510(K)	K072260	2007-11-27	NUFACE, MODEL NU-4003	FDA record →
Newtowne Hyperbarics	Hyperbaric Oxygen Chambers	510(K)	K051759	2005-11-17	FLEXI-LITE, MODEL FL-V1.2	FDA record →
OxyHealth	Hyperbaric Oxygen Chambers	510(K)	K041007	2004-11-15	MILLENIUM, MODELS 2000, 2001 AND 2002	FDA record →

§ Data sourced from openFDA and refreshed by scripts/populate-fda-clearances.mjs. We do not host FDA data ourselves — every record links to the canonical entry on accessdata.fda.gov for verification.