FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
K Number: K033136
·
Decision Mar 5, 2004
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
11
Review Days
157
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Basic Information
- Device Name
- I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
- K Number
- K033136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innova Vision, Inc.
- Date Received
- September 30, 2003
- Decision Date
- March 5, 2004
- Product Code
- LPL
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Other Clearances by Innova Vision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | Apr 17, 2024 | Substantially Equivalent |
| K232139 | Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Nov 16, 2023 | Substantially Equivalent |
| K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens | Mar 13, 2023 | Substantially Equivalent |
| K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | May 13, 2022 | Substantially Equivalent |
| K112373 | CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION | Aug 17, 2012 | Substantially Equivalent |
| K083288 | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER | Sep 3, 2009 | Substantially Equivalent |
| K073060 | CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Nov 29, 2007 | Substantially Equivalent |
| K062541 | CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Jun 7, 2007 | Substantially Equivalent |
| K053191 | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS | May 12, 2006 | Substantially Equivalent |
| K051129 | DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Aug 12, 2005 | Substantially Equivalent |