Intelliwave4— 510(k) K142641
Substantially EquivalentArt Optical Contact Lens, Inc.
FDA 510(k) clearance K142641 for Intelliwave4, Substantially Equivalent on 2015-01-12. Applicant: Art Optical Contact Lens, Inc.. Device class: 2.
Clearance details
- Applicant
- Art Optical Contact Lens, Inc.
- Product code
- Code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code LPL
view all- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
More clearances from Art Optical Contact Lens, Inc.
view all- K230824 — IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
- K172314 — Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
- K152046 — Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
- K100221 — INTELLIWAVE3
- K073621 — INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.