Data / Medical devices / United States / Luna X Inc

Luna X Inc: FDA-registered device maker in Sioux Falls, SD, United States, 9 510(k) clearances

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

Luna X Inc is registered with the FDA (registration 3038373471) in Sioux Falls, SD, United States. It lists 9 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 11, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3038373471
Address: 4809 W 41st St Ste 202 # 171, Sioux Falls, SD, United States, 57106
Owner or operator: Luna X Inc (10093433)
Roles: Complaint file establishment
First device listed: May 15, 2025
Registered through: 2027
Brand names listed: BEAR, BEAR 2 Body, BEAR 2 Eyes and Lips, BEAR 2 go, BEAR MINI, Bear 2, ESPADA 2, FAQ 101 and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Complaint file establishment	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Complaint file establishment	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Complaint file establishment	accessdata.fda.gov
Light Based Over-The-Counter Hair Removal	OHT	2	Complaint file establishment	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Complaint file establishment	accessdata.fda.gov
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	PAY	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Transcutaneous Electrical, Aesthetic Purposes	NFO	2	Complaint file establishment	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	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
December 11, 2024	K242747	FAQ (302)	OAP	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov
August 20, 2024	K241102	Luna 4 plus	OHS	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov
July 15, 2024	K240616	FAQ (102)	PAY	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov
May 13, 2024	K232242	BEAR 2 Body	NFO	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov
April 19, 2024	K240378	FAQ 201, FAQ 202	OHS	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov
September 25, 2023	K231977	PEACH 2, PEACH 2 Duo, PEACH 2 go	OHT	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov
April 5, 2023	K222012	FAQ 101	PAY	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov
July 31, 2020	K200803	BEAR and BEAR mini	NFO	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov
November 30, 2016	K162450	ESPADA Acne-Clearing Blue Light Pen	OLP	Substantially Equivalent	Foreo, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 11, 2024. 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.