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510(k) K152996

Molteno3 Glaucoma Implant by Innovative Ophthalmic Products, Inc. (Iop) — Product Code KYF

K152996 is an FDA 510(k) premarket notification submitted by Innovative Ophthalmic Products, Inc. (Iop) for the device "Molteno3 Glaucoma Implant". The FDA issued a decision of Substantially Equivalent on December 17, 2015. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
October 13, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type

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  • K182518 — AHMED ClearPath Glaucoma Drainage Device (January 18, 2019)
  • K171451 — Ahmed Glaucoma Valve Model FP8 (August 8, 2017)
  • K161457 — XEN Glaucoma Treatment System (November 21, 2016)
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  • K062252 — MOLTENO3 (September 27, 2006)
  • K060644 — AHMED GLAUCOMA VALVE, MODEL M4 (September 18, 2006)
  • K030350 — EXPRESS MINI GLAUCOMA SHUNT (March 13, 2003)

FDA data resources