510(k) Report

PMA · Approved

Approved

Viewpoint CK System

P010018/S005PMAApproved Mar 16, 2004202-day reviewClass III

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Refractec, Inc. · MWD Electrosurgical, Radio Frequency, Refractive Correction

Approved on Mar 16, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 202-day review.

Decided
Mar 16, 2004
Review
202 days
Class
Class III
Product code
MWD
Recalls
None

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

FIG. 1 — Lineage of P010018/S005Source: FDA PMA database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MWD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MWD devices

MWD Electrosurgical, Radio Frequency, Refractive Correction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWD

FDA has decided no MWD device since 2007.

Median 510(k) review, days · MWD

Too few MWD 510(k)s in any year since 2007 to give a median.

Recalls per year · MWD

No recall names MWD since 2007.

Adverse event reports per year · MWD

No MAUDE report names MWD since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Refractec, Inc.

12 FDA decisions under this applicant name. See the company

  • P010018/S009Viewpoint CK SystemRefractec, Inc. · 2006
  • K053475Optipoint Corneal Marker, Model VPT-Opt-450Refractec, Inc. · 2006
  • P010018/S008Viewpoint CK SystemRefractec, Inc. · 2005
  • P010018/S007Viewpoint Conductive Keratoplasty SystemRefractec, Inc. · 2005
  • P010018/S006Viewpoint CK SystemRefractec, Inc. · 2004

Recent decisions in MWD

The MWD category page

https://510kreport.com/device/P010018/S005 · printed Nov 5, 2026

Cite this page

510(k) Report. “P010018/S005: Viewpoint CK System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P010018/S005

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026