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: HYPERION LTK SYSTEM
• Classification Name: laser, ophthalmic
• Generic Name: ophthalmic medical laser system
• Regulation Number: 886.4390
• Applicant: 20/20 TECHNOLOGIES, INC
• PMA Number: P990078
• Supplement Number: S005
• Date Received: 08/20/2001
• Decision Date: 05/08/2002
• Product Code: HQF [ Registered Establishments with HQF ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: location change: manufacturer
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a manufacturing site located at a-plus/c-mac, fremont, california.