MEL 80 Excimer Laser System
PMA P060004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP060004 | Date11 Aug 2006 | 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- Withdrawn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
- Generic name
- Excimer laser system
- PMA number
- FDA product code
- LZS
- Device class
- Class III
- Advisory committee
- Ophthalmic
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The MEL 80 Excimer Laser System is an excimer laser device classified as a Class III medical device, designed for primary laser-assisted in situ keratomileusis (LASIK) procedures. It employs an optical zone of 6.0 to 7.0 mm in diameter with a transition zone of 1.7 to 1.9 mm, achieving a total ablation diameter of 7.7 to 8.9 mm. This system is intended for correcting myopia up to -7.0 diopters, with or without astigmatism up to -3.0 diopters, in patients aged 21 or older with stable refractive error.
The MEL 80 Excimer Laser System is supplied as a reusable medical device and is approved for use in ophthalmic settings. It requires sterile conditions during surgical procedures and is regulated under an FDA Premarket Approval (PMA) with PMA number P060004. The device is intended for single-patient use per procedure, adhering to standard surgical protocols for LASIK treatments. Storage and handling must comply with manufacturer guidelines to maintain performance and sterility.
Other devices from Carl Zeiss Meditec, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the MEL 80 Excimer Laser System used for?
The MEL 80 Excimer Laser System is designed for primary laser-assisted in situ keratomileusis (LASIK) procedures to correct myopia up to -7.0 diopters, with or without astigmatism up to -3.0 diopters, in patients aged 21 or older with stable refractive error.
How is the MEL 80 Excimer Laser System supplied?
The MEL 80 Excimer Laser System is supplied as a reusable medical device intended for single-patient use per procedure. It requires sterile conditions during surgical procedures and must be stored and handled according to manufacturer guidelines to maintain performance and sterility.
What are the optical specifications of the MEL 80 Excimer Laser System?
The MEL 80 Excimer Laser System employs an optical zone of 6.0 to 7.0 mm in diameter with a transition zone of 1.7 to 1.9 mm, achieving a total ablation diameter of 7.7 to 8.9 mm for LASIK treatments.
What is the regulatory status of the MEL 80 Excimer Laser System?
The MEL 80 Excimer Laser System is regulated under an FDA Premarket Approval (PMA) with PMA number P060004, classified as a Class III medical device for ophthalmic use.