Centauri Yag Laser Syst, Ophthamology

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K904630 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Altair

  Class II

  FDA 510(k) K905072 Active Cleared 7 Feb 1991

• Sirius

  Class II

  FDA 510(k) K912813 Active Cleared 31 Dec 1991

• Orion Yag Laser System Ophthalmology

  Class II

  FDA 510(k) K910826 Active Cleared 16 Nov 1993

• Pegasus with Accessories

  Class II

  FDA 510(k) K903027 Active Cleared 2 Oct 1990

• Polaris

  Class II

  FDA 510(k) K910341 Active Cleared 11 Oct 1991

• Centauri/Pegasus

  Class II

  FDA 510(k) K905737 Active Cleared 17 Jun 1991

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• What types of ophthalmologic procedures is the Centauri YAG Laser System specifically designed to perform?

  The Centauri YAG Laser System is designed for precise intraocular surgeries, including posterior capsule cleavage (such as YAG capsulotomy) and iridotomy. It uses a neodymium:yttrium-aluminum-garnet (YAG) laser to perform tissue ablation, which is particularly useful for breaking adhesions or creating openings in the eye’s lens capsule or iris. It is intended for use by trained ophthalmologists in clinical settings.

• Can the Centauri YAG Laser System be reused, or is it meant for single-use only?

  The Centauri YAG Laser System is authorized for both single-use and reusable applications, depending on facility protocols. If reused, strict adherence to sterile techniques and proper maintenance protocols is required to ensure safety and efficacy. Always follow your institution’s established guidelines for device reprocessing.

• What safety measures must be followed when using the Centauri YAG Laser System?

  Since this is a powered laser surgical instrument, it requires strict compliance with laser safety protocols to protect patients and staff. The device is classified under FDA Product Code GEX (Class II) with special controls, meaning it must be used by trained ophthalmologists in controlled clinical environments. Facility protocols should include proper sterilization (if reusable), eye protection for personnel, and adherence to manufacturer guidelines for safe operation.

• How was the regulatory approval for the Centauri YAG Laser System determined?

  The device received FDA clearance through a 510(k) submission (K904630) under the Substantially Equivalent (SESE) determination, meaning it was found to be comparable to a legally marketed predicate device. The review was conducted by the General Plastic Surgery (SU) Advisory Committee and falls under FDA product code GEX for powered laser surgical instruments, classified as Class II with special controls.