FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES
FDA premarket approval P830037/S047 · decided 2002-11-26
Approval details
- PMA number
- P830037
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2002-10-25
- Decision date
- 2002-11-26
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR AN ADDITIONAL COLORANT TO BE USED IN THE COLORANT PROCESS AND A REVISION TO THE LABELING TO MOVE THE STATEMENT "THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE" FROM THE ACTIONS SECTION OF THE PACKAGE INSERT TO THE INDICATIONS SECTION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FRESHOOK TRADE NAME WITH THE FOLLOWING INDICATIONS: VISION CORRECTION SPHERICAL: FRESHLOOK SPHERICAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION
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510(k) clearances by this applicant
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| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |