PMA P990010S001

Device: VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
Applicant: Amo Manufacturing USA, LLC
PMA number: P990010
Supplement: S001
Product code: LZS
Decision date: 2000-04-20
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: The device, as modified, will be marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (PRK) and myopic and astigmatic laser assisted in-situ keratomileusis (LASIK).

Current openFDA PMA Record#

Device: VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
Applicant: Amo Manufacturing USA, LLC
PMA number: P990010
Supplement: S001
Product code: LZS
Generic name: Excimer laser system
Decision date: 2000-04-20
Decision code: APPR
Date received: 2000-04-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: The device, as modified, will be marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (PRK) and myopic and astigmatic laser assisted in-situ keratomileusis (LASIK).