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510(k) K230824

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) by Art Optical Contact Lens, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2023
Date Received
March 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Art Optical Contact Lens, Inc.

  • K172314 — Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) (September 20, 2017)
  • K152046 — Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilc (November 24, 2015)
  • K142641 — Intelliwave4 (January 12, 2015)
  • K100221 — INTELLIWAVE3 (September 14, 2010)
  • K073621 — INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND (July 3, 2008)

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