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510(k) K041008

EYE-CEPT REWETTING DROPS by Optics Laboratory, Inc. — Product Code LPN

K041008 is an FDA 510(k) premarket notification submitted by Optics Laboratory, Inc. for the device "EYE-CEPT REWETTING DROPS". The FDA issued a decision of Substantially Equivalent on July 1, 2005. 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
July 1, 2005
Date Received
April 19, 2004
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)
  • K110221 — EYE-CEPT STERILE SALINE SOLUTION (November 1, 2011)

Other clearances for product code LPN

  • K253795 — MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution (August 13, 2026)
  • 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)

FDA data resources