Kremer Excimer Laser System Serial No. KEA940202

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Kremer Laser System

Generic Name

Excimer laser system

PMA Number

P970005 ↗

FDA Product Code

LZS

Device Class

Class III

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

• Ultraedge Keratome Blade, Model 374803 - Acs

  Class I

  FDA 510(k) K001144 Active Cleared 5 May 2000

• Automated Disposable Keratome (Adk)

  Class I

  FDA 510(k) K974004 Active Cleared 8 Jan 1998

• Ultrashaper Keratome

  Class I

  FDA 510(k) K990227 Active Cleared 31 Jan 2000

• Laserscan LSX Excimer Laser System

  Class III

  FDA PMA P980008 Active Approved 12 Nov 1999

• What types of vision corrections can the Kremer Laser System address, and what age group is it approved for?

  The Kremer Laser System is FDA-authorized for myopic (nearsightedness) and astigmatic LASIK procedures, correcting myopia between -1.0 and -15.0 diopters with or without astigmatism up to 5.00 diopters. It is intended for patients aged 18 and older with stable refraction, though younger patients (18–20 years) must show minimal refraction shifts (≤0.5D) prior to surgery, while those 21+ must demonstrate ≤1.0D stability over the prior year.

• Is the Kremer Laser System designed for single-use or reusable applications, and what maintenance is required?

  The Kremer Laser System is supplied as a reusable medical device and requires proper handling, calibration, and maintenance to ensure safe and effective performance. Since it is not sterile by design, it must be cleaned, disinfected, and serviced according to manufacturer guidelines between uses in clinical settings.

• How does the ablation zone size of the Kremer Laser System influence its use in LASIK procedures?

  The Kremer Laser System employs a **6.0 mm ablation zone**, which determines the precise corneal area reshaped during LASIK. This fixed zone size is optimized for correcting myopia and astigmatism within the specified diopter ranges (-1.0 to -15.0D myopia, up to 5.00D astigmatism) while maintaining predictable outcomes for patients aged 18+ with stable refraction.

• What regulatory pathway was followed for the Kremer Laser System’s FDA authorization, and what does this mean for clinicians?

  The Kremer Laser System received FDA authorization via a **Premarket Approval (PMA)** under PMA number **P970005**, indicating a rigorous review process for high-risk Class III devices. Clinicians should confirm compliance with the manufacturer’s maintenance protocols and follow the approved indications (e.g., diopter ranges, patient age/stability criteria) to ensure safe and effective use in LASIK procedures.