VIEWPOINT CK SYSTEM
FDA premarket approval P010018/S005 · decided 2004-03-16
Approval details
- PMA number
- P010018
- Supplement
- S005
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VIEWPOINT CK SYSTEM
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Applicant
- Refractec, Inc.
- Date received
- 2003-08-27
- Decision date
- 2004-03-16
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- MWD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE VIEWPOINT CK SYSTEM. THE DEVICE IS INDICATED FOR THE TEMPORARY INDUCTION OF MYOPIA (-1.00 D TO -2.00 D) TO IMPROVE NEAR VISION IN THE NON-DOMINANT EYE OF PRESBYOPIC HYPEROPES OR PRESBYOPIC EMMETROPES, VIA SPHERICAL HYPEROPIC TREATMENT OF 1.00 TO 2.25 D, IN PATIENTS: 1) 40 YEARS OF AGE OF GREATER; 2) WITH A DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF <0.50 D IN SPHERICAL AND CYLINDRICAL COMPONENTS OF THE MANIFEST REFRACTION; 3) WITH
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 (K053475) | Refractec, Inc. | 2006-03-03 |
| REFRACTEC MCS-100 (K980522) | Refractec, Inc. | 1998-07-22 |