Data / Medical devices / Taiwan / Lightmed Corp.

Lightmed Corp.: FDA-registered device maker in New Taipei City, Taiwan, 8 510(k) clearances

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

Lightmed Corp. is registered with the FDA (registration 3008156177) in New Taipei City, Taiwan. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 24, 2019. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008156177
FEI number: 3003559308
Address: No.1-1, Lane 1, Sec. 3, Pao An St., Shulin Dist., New Taipei City, Taiwan, 23861
Owner or operator: LIGHTMED CORP. (9040850)
Roles: Manufacturer
First device listed: December 31, 2007
Registered through: 2027
Brand names listed: LightLas 532, LightLas 532, DermaLight, LightLas 577, LightLas 810, LightLas Pattern Scanning System, LightLas SeLecTor Deux, LightLas YAG, LIGHTLas YAG "PT", LPULSA SYL9000, LightMed TruScan577 and more

Devices it lists

Device	Product code	Class	Role	Source
Laser, Ophthalmic	HQF	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Table, Instrument, Powered, Ophthalmic	HRJ	1	Manufacturer	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
May 24, 2019	K190448	LightLas Pattern Scanning System - TruScan Pro	HQF	Substantially Equivalent	Light-Med(Usa), Inc.	accessdata.fda.gov
February 27, 2015	K142172	LIGHTMED TRUSCAN 577	HQF	Substantially Equivalent	Lightmed Corp.	accessdata.fda.gov
September 28, 2009	K091981	LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER	HQF	Substantially Equivalent	Lightmed Corp.	accessdata.fda.gov
September 18, 2009	K091534	LIGHTLAS MODEL 532	HQF	Substantially Equivalent	Lightmed Corp.	accessdata.fda.gov
August 13, 2009	K090774	LIGHTLAS SELECTOR	HQF	Substantially Equivalent	Lightmed Corp.	accessdata.fda.gov
August 8, 2002	K021538	LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR	HQF	Substantially Equivalent	Lightmed Corp.	accessdata.fda.gov
August 22, 2001	K010372	LIGHTLAS 532 PHOTOCOAGULATOR	HQF	Substantially Equivalent	Lightmed Corp.	accessdata.fda.gov
March 30, 1999	K990075	LPULSA SYL-9000 OPHTHALMIC YAG LASER	HQF	Substantially Equivalent	Light-Med(Usa), Inc.	accessdata.fda.gov

Compare with other makers

Updated May 24, 2019. 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.