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510(k) K120821

LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM by Misder, LLC — Product Code OCT

K120821 is an FDA 510(k) premarket notification submitted by Misder, LLC for the device "LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 11, 2012. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2012
Date Received
March 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

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  • K102452 — DEFOGGING AND CLEANING SOLUTION- FLO-X (December 23, 2010)
  • K080613 — CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 (November 6, 2008)

FDA data resources