Merchsource LLC

Irvine, CA, US

MERCHSOURCE LLC appears in FDA device records in Irvine, CA. FDA records list 3 510(k) clearances between 2025-10-01 and 2025-10-30, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Merchsource LLC in 2025.

Clearances by year, as a table

510(k) clearance decisions for Merchsource LLC, by decision year
Year	Clearances
2025	3

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K251531	AIR COMPRESSION BOOTS 1018195,1018196	IRP	Substantially Equivalent	2025-10-30
K252093	Light Therapy Mask (1019055)	OHS	Substantially Equivalent	2025-10-16
K252096	Light Therapy Decollete Mask (1019135)	OHS	Substantially Equivalent	2025-10-01

Registered establishments

FDA registered establishments for Merchsource LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004126239	3004126239	MERCHSOURCE LLC	7755 Irvine Center Drive, Irvine, CA 92618 US	2026	HQY ILS ILY IMB IME IPS IRP IRT ISA ITJ and 2 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1661-2022	The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.	Excessive ultraviolet-C radiation	Class II	2022-08-01	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain