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510(k) K071203

SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES by Optikem International, Inc. — Product Code LPN

K071203 is an FDA 510(k) premarket notification submitted by Optikem International, Inc. for the device "SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on June 13, 2007. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Optikem International, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2007
Date Received
May 1, 2007
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 Optikem International, Inc.

  • K822495 — LE CASE HARD CONTACT LENS STORAGE CASE (September 30, 1982)

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