FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
K Number: K150590
·
Decision Jul 10, 2015
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
18
Review Days
123
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Basic Information
- Device Name
- CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
- K Number
- K150590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Contamac, Ltd.
- Date Received
- March 9, 2015
- Decision Date
- July 10, 2015
- 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 Contamac, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Mar 17, 2022 | Substantially Equivalent |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | Nov 23, 2018 | Substantially Equivalent |
| K181566 | Nutrifill | Oct 22, 2018 | Substantially Equivalent |
| K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens | Apr 25, 2018 | Substantially Equivalent |
| K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | Oct 24, 2017 | Substantially Equivalent |
| K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses | Aug 1, 2017 | Substantially Equivalent |
| K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Aug 10, 2016 | Substantially Equivalent |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | Jul 13, 2016 | Substantially Equivalent |
| K081178 | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES | Oct 9, 2008 | Substantially Equivalent |
| K070628 | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. | May 1, 2007 | Substantially Equivalent |