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510(k) K110221

EYE-CEPT STERILE SALINE SOLUTION by Optics Laboratory, Inc. — Product Code LPN

K110221 is an FDA 510(k) premarket notification submitted by Optics Laboratory, Inc. for the device "EYE-CEPT STERILE SALINE SOLUTION". The FDA issued a decision of Substantially Equivalent on November 1, 2011. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Optics Laboratory, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2011
Date Received
January 25, 2011
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.

  • K161622 — LensGiene Sterile Saline Solution (August 11, 2016)
  • K041008 — EYE-CEPT REWETTING DROPS (July 1, 2005)

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