Electrosurgical, Radio Frequency, Refractive Correction
Basic Information
- Device Name
- Electrosurgical, Radio Frequency, Refractive Correction
- Trade Name
- VIEWPOINT(TM) CK SYSTEM
- PMA Number
- P010018
- Device Class
- FDA Class 3
- Product Code
- MWD
- Generic Name
- Electrosurgical, radio frequency, refractive correction
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 11, 2002
- Date Received
- March 14, 2001
- Expedited Review
- N
- Docket Number
- 02M-0174
Advisory Committee 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 CYLINDRICAL COMPONENTS OF THE MANIFEST REFRACTION. THE MAGNITUDE OF CORRECTION WITH THIS TREATMENT DIMINISHES OVER TIME, WITH SOME PATIENTS RETAINING SOME OR ALL OF THEIR INTENDED REFRACTIVE CORRECTION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MWD | Electrosurgical, Radio Frequency, Refractive Correction | FDA class 3 | Unknown |