FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM

K Number: K023249 · Decision Oct 18, 2002
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
3
Applicant Total
43
Review Days
18

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Basic Information

Device Name
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
K Number
K023249
Device Class
FDA class 1
Clearance Type
Abbreviated
Regulation Number
886.1760
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Alcon Laboratories, Inc.
Date Received
September 30, 2002
Decision Date
October 18, 2002
Product Code
NCF
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
NCF Aberrometer, Ophthalmic

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K242184 Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
K233876 UNITY VCS (8065000296); UNITY CS (8065000297)
K233902 Centurion™ Vision System (Active Sentry™) (8065753057)
K233856 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
K232921 DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric
K230785 Precision1, Precision1 for Astigmatism
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