FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
K Number: K172314
·
Decision Sep 20, 2017
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
117
Applicant Total
6
Review Days
50
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Basic Information
- Device Name
- Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
- K Number
- K172314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Art Optical Contact Lens, Inc.
- Date Received
- August 1, 2017
- Decision Date
- September 20, 2017
- Product Code
- HQD
- 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 |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
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Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
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Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
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Other Clearances by Art Optical Contact Lens, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230824 | IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Sep 6, 2023 | Substantially Equivalent |
| K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) | Nov 24, 2015 | Substantially Equivalent |
| K142641 | Intelliwave4 | Jan 12, 2015 | Substantially Equivalent |
| K100221 | INTELLIWAVE3 | Sep 14, 2010 | Substantially Equivalent |
| K073621 | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | Jul 3, 2008 | Substantially Equivalent |