FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K Number: K073060
·
Decision Nov 29, 2007
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
24
Applicant Total
11
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K Number
- K073060
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innova Vision, Inc.
- Date Received
- October 30, 2007
- Decision Date
- November 29, 2007
- Product Code
- MVN
- 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 |
|---|---|---|---|
| MVN | Lens, Contact, (Disposable) | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MVN), ordered by most recent decision date.
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
FDA 510(k)
FDA Class 2
·Ophthalmic
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
FDA 510(k)
FDA Class 2
·Ophthalmic
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
FDA 510(k)
FDA Class 2
·Ophthalmic
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
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 |
| 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 |
| K033136 | I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 | Mar 5, 2004 | Substantially Equivalent |