FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

LCA 2000

K Number: K871034 · Decision Apr 10, 1987
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
25
Applicant Total
5
Review Days
24

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Basic Information

Device Name
LCA 2000
K Number
K871034
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4580
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Vistek Corp.
Date Received
March 17, 1987
Decision Date
April 10, 1987
Product Code
FTA
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
FTA Light, Surgical, Accessories

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K Number Device Name
K904682 VISTEK ELECTRONIC CONTROLLER
K904681 VLS 5300 300W XENON LIGHT SOURCE
K860173 VIS-2000 VIDEO SYSTEM
K843806 VIS-1000 VIDEO SYSTEM