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510(k) K161622

LensGiene Sterile Saline Solution by Optics Laboratory, Inc. — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2016
Date Received
June 13, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Optics Laboratory, Inc.

  • K110221 — EYE-CEPT STERILE SALINE SOLUTION (November 1, 2011)
  • K041008 — EYE-CEPT REWETTING DROPS (July 1, 2005)

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