FDA 510(k) Application Details - K010372

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K010372
Device Name	Laser, Ophthalmic
Applicant	LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 SHULIN CITY 238 TW Other 510(k) Applications for this Company
Contact	GARY LEE Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2001
Decision Date	08/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review