Electrosurgical, Radio Frequency, Refractive Correction
Basic Information
- Device Name
- Electrosurgical, Radio Frequency, Refractive Correction
- Trade Name
- VIEWPOINT CK SYSTEM
- PMA Number
- P010018
- Supplement Number
- S005
- 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
- March 16, 2004
- Date Received
- August 27, 2003
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 04M-0134
Advisory Committee 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 <=0.75 D OF CYCLOPLEGIC REFRACTIVE CYLINDER; AND 4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION WEAR (I.E., DOMINANT EYE CORRECTED FOR DISTANCE VISION AND NON-DOMINANT EYE CORRECTED FOR NEAR VISION).
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 |