VIEWPOINT(TM) CK SYSTEM
FDA premarket approval P010018 · decided 2002-04-11
Approval details
- PMA number
- P010018
- Trade name
- VIEWPOINT(TM) CK SYSTEM
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Applicant
- Refractec, Inc.
- Date received
- 2001-03-14
- Decision date
- 2002-04-11
- Days to decision
- 393 days
- Decision code
- APPR
- Product code
- MWD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE REFRACTEC VIEWPOINT CK SYSTEM. THIS DEVICE IS INDICATED FOR: TEMPORARY REDUCTION OF SPHERICAL HYPEROPIA IN PATIENTS WHO HAVE 0.75 D TO 3.25 D OF CYCLOPLEGIC SPHERICAL HYPEROPIA, LESS THAN OR EQUAL TO 0.75 D OF REFRACTIVE ASTIGMATISM (MINUS CYLINDER FORMAT), A CYCLOPLEGIC SPHERICAL EQUIVALENT OF 0.75 D TO 3.00 D, AND ARE 40 YEARS OF AGE OR GREATER WITH A DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTH, AS DEMONSTRATED BY A CHANGE OF LESS THAN 0.50 D IN SPHERICAL AND CYL
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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 |