Light-Med (USA), Inc.

San Clemente, CA, US

LIGHT-MED (USA), INC. appears in FDA device records in San Clemente, CA. FDA records list 4 510(k) clearances between 1999-03-30 and 2019-07-01, 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: 4
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Light-Med (USA), Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Lightmed USA, Inc.510(k), recall

510(k) clearance history

FDA records hold 4 510(k) clearances for Light-Med (USA), Inc. between 1999 and 2019. The busiest year on record is 2019, with 2. The most recent is 2019, with 2.

Clearances by year, as a table

510(k) clearance decisions for Light-Med (USA), Inc., by decision year
Year	Clearances
1999	1
2018	1
2019	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K183173	LIGHTMED Ultrasound System	IYO	Substantially Equivalent	2019-07-01
K190448	LightLas Pattern Scanning System - TruScan Pro	HQF	Substantially Equivalent	2019-05-24
K170761	LIGHTSonic BUBM	IYO	Substantially Equivalent	2018-04-13
K990075	LPULSA SYL-9000 OPHTHALMIC YAG LASER	HQF	Substantially Equivalent	1999-03-30

Registered establishments

FDA registered establishments for Light-Med (USA), Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2087483	3003976404	LIGHT-MED (USA), INC.	1130 Calle Cordillera, SAN CLEMENTE, CA 92673 US	2026	No device listings on this registration

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-0228-04	Model LightLas 532 Opthalmic Photocoagulator Laser	Firm needed to include calibration procedures in user guide.		2003-11-11	Terminated

Verification record

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