Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: VIEWPOINT CK SYSTEM
• Classification Name: electrosurgical,radio frequency,refractive correction
• Generic Name: rf electrosurgical device
• Applicant: REFRACTEC, INC.
• PMA Number: P010018
• Supplement Number: S008
• Date Received: 09/08/2005
• Decision Date: 09/30/2005
• Product Code: MWD
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Implementation of a controlled adhesive application process to more accurately control the amount of adhesive applied.