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510(k) K991995

SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS by Softchrome, Inc. — Product Code MZD

K991995 is an FDA 510(k) premarket notification submitted by Softchrome, Inc. for the device "SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS". The FDA issued a decision of Substantially Equivalent on August 27, 1999. The device falls under product code MZD (System, In-Office Tinting, Contact Lenses), a Class II device regulated under 21 CFR 886.5925.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1999
Date Received
June 14, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, In-Office Tinting, Contact Lenses
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

FDA data resources