Viewpoint Ck System (Keratoplast Tip Component)
PMA P010018
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP010018 | Date11 Apr 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Viewpoint(Tm) Ck System
- Generic Name
- Electrosurgical, radio frequency, refractive correction
- PMA Number
- FDA Product Code
- MWD
- Device Class
- Class III
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Viewpoint CK System is an electrosurgical, radio frequency device designed for refractive correction. It is indicated for the temporary reduction of spherical hyperopia in patients aged 40 years or older who meet specific refractive criteria, including a cycloplegic spherical hyperopia range of 0.75 D to 3.25 D and minimal refractive astigmatism.
This system is manufactured by Refractec, Inc. and has received FDA PMA approval for its intended clinical use. The magnitude of refractive correction achieved with this treatment may diminish over time, with results varying among patients regarding the retention of the intended correction.
Other devices from Refractec, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary function of the Viewpoint CK System?
The Viewpoint CK System is an electrosurgical, radio frequency device used for the temporary reduction of spherical hyperopia in patients who meet specific refractive and age-related criteria.
Is the refractive correction provided by this system permanent?
No, the magnitude of correction provided by the Viewpoint CK System diminishes over time, meaning the effect is considered temporary rather than permanent.
Who is a candidate for treatment with the Viewpoint CK System?
Candidates must be 40 years of age or older with 0.75 D to 3.25 D of cycloplegic spherical hyperopia, less than or equal to 0.75 D of refractive astigmatism, and documented stability of refraction for the prior 12 months.