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HOY — Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Class I

FDA Device Classification

Classification Details

Product Code
HOY
Device Class
Class I
Regulation Number
886.4750
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K132042x6dAMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPANDApril 28, 2014
K050856ophthocareLCG (LIQUIDE CRYSTAL GLASSES) SYSTEMMay 31, 2005
K971465national healthcare mfgNATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYSJune 4, 1997
K944700sungold eyewearARCTIC PREMIER SERIESDecember 22, 1994
K944857sellstrom mfgGOGGLE SAFEGUARDDecember 15, 1994
K945351taiwan eva industrial coSHIELD, EYE, OPHTHALMICDecember 13, 1994
K945346universal massage and tanningMAKROLON 2405 GOGGLES (LIGHT AND DARK)November 22, 1994
K942407amcon laboratoriesAMCON SLIP IN MYDRIATIC SUNGLASSESJune 6, 1994
K941829klinger eye shieldsSUN FILTERS/SHIELDSMay 17, 1994
K930347depuySHAIDS PROTECTIVE GLASSESApril 29, 1994
K940275p.j. productsUNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELDMarch 24, 1994
K940213p.j. productsUNIVERSAL CUSHIONED METAL EYE SHIELDMarch 24, 1994
K930840aukland medical plasticsPOST-MYDS(TM)March 1, 1994
K940095p.j. productsFOX EYE ALUMINUM SHIELD, OPHTHALMICMarch 1, 1994
K931254sellstrom mfgGOGGLE SAFEGUARDNovember 12, 1993
K934085american threshold industriesMODIFICATION OF SURGICAL EYESHIELD MASKNovember 12, 1993
K925564action eyewearACTION MEDTEK/DENTEK EYEGLASSESOctober 7, 1993
K912576katena productsINSTRUMENT WIPE AND CORNEAL SHIELDJanuary 31, 1992
K914095california suncarePEEPERS TANNING GOGGLESOctober 30, 1991
K913230welch allynUNIDIRECTIONAL OCCLUDEROctober 2, 1991