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510(k) K211361

3N Contact Lenses Adjunct Cleaner by Suzhou 3N Biological Technology Co., Ltd. — Product Code LYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2022
Date Received
May 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

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  • K974724 — SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS (March 2, 1998)
  • K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (December 20, 1996)