FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM

K Number: K050856 · Decision May 31, 2005
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
1
Review Days
56

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Basic Information

Device Name
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
K Number
K050856
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
886.4750
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Ophthocare , Ltd.
Date Received
April 5, 2005
Decision Date
May 31, 2005
Product Code
HOY
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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