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510(k) K210051

OTE MPS 045 Multi-purpose Lens Care Solution by Ote North America, LLC — Product Code LPN

K210051 is an FDA 510(k) premarket notification submitted by Ote North America, LLC for the device "OTE MPS 045 Multi-purpose Lens Care Solution". The FDA issued a decision of Substantially Equivalent on May 26, 2021. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2021
Date Received
January 8, 2021
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

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  • K191795 — AOCup Lens Case with AODisc (July 31, 2019)
  • K170483 — Bausch + Lomb Sensitive Eyes Plus Saline Solution (April 11, 2017)
  • K161819 — NNR06 Multi-Purpose Solution (November 25, 2016)

FDA data resources