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510(k) K002319

PURILENS SALINE SOLUTION by Purilens, Inc. — Product Code LPN

K002319 is an FDA 510(k) premarket notification submitted by Purilens, Inc. for the device "PURILENS SALINE SOLUTION". The FDA issued a decision of Substantially Equivalent on August 30, 2000. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Purilens, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2000
Date Received
July 31, 2000
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 Purilens, Inc.

  • K991965 — PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (October 1, 1999)

Other clearances for product code LPN

  • K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (December 6, 2022)
  • 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)
  • K200747 — PuriLens Plus Preservative Free Saline (May 15, 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)

FDA data resources