HQG — Lens, Spectacle, Non-Custom (Prescription) Class I

FDA Device Classification

Classification Details

Product Code
HQG
Device Class
Class I
Regulation Number
886.5844
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K935919ja-ruSUNGLASSESFebruary 16, 1994
K920795optical radiation0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEXJuly 13, 1992
K900091onufryk low vision entMODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTORApril 4, 1990
K884360seikoSEIKO P-6 PROGRESSIVE SPECTACLE LENSESNovember 15, 1988
K882814neolensNEOLENS PRESCRIPTION SPECTACLE LENSJuly 29, 1988
K882308automated lens systemCR-39 PLASTIC LENSES FOR EYEGLASSESJuly 22, 1988
K881225beta optical coOPHTHALMIC SPECTACLE LENS BLANKSApril 19, 1988
K875063epson el pasoSEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.February 22, 1988
K874681klockner contract packagingSWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYESFebruary 5, 1988
K873245seiko optical products of americaAR DIACOAT SINGLE VISION LENSESOctober 5, 1987
K872506aura lens productsMELANITE IJuly 27, 1987
K871961korea asahi optical coMULTIPLE SPECTACLE LENSJune 3, 1987
K865103neo opticsKROM-X LENS SYSTEMJanuary 20, 1987
K863367vision-sciencesFORMALENS 2000September 26, 1986
K862578techna visionTECHNA VISION CASTING RESINJuly 23, 1986
K861021private eyes sunglassGOTTEX SUNGLASSESJune 17, 1986
K861960asahi optical co. c/o rosati associates, p.cZIMLITE LENSJune 9, 1986
K861162efopLENS SPECTACLE NON-CUSTOM (PRESCRIPTION)June 9, 1986
K861759h. girardGIRARD SUNGLASSES (NON-PRESCRIPTION)June 9, 1986
K861684seiko optical products of americaSEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)June 9, 1986