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510(k) K200747

PuriLens Plus Preservative Free Saline by The Lifestyle Company, Inc. — Product Code LPN

K200747 is an FDA 510(k) premarket notification submitted by The Lifestyle Company, Inc. for the device "PuriLens Plus Preservative Free Saline". The FDA issued a decision of Substantially Equivalent on May 15, 2020. 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 15, 2020
Date Received
March 23, 2020
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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  • K221263 — Aqua Naina Plus Sterile Saline Solution (October 12, 2022)
  • K202932 — ABT12 multi-purpose solution (May 28, 2021)
  • K210051 — OTE MPS 045 Multi-purpose Lens Care Solution (May 26, 2021)
  • K193441 — Aqua Naina Sterile Saline Solution (May 26, 2020)
  • K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (March 2, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • 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