Centauri/Pegasus
by Pfizer Laser Systems 2 variants
510(k) K905802
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905802 | Date19 Jul 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Centauri/Pegasus is a Powered Laser Surgical Instrument, classified under product code GEX. This device is designed for laser-based surgical procedures, delivering precise energy for tissue ablation, coagulation, or vaporisation in general and plastic surgery applications. Its functionality relies on laser technology to perform controlled surgical interventions with minimal thermal spread, enhancing procedural accuracy and reducing collateral damage.
The Centauri/Pegasus is supplied as a reusable medical device, intended for use in sterile surgical environments. It is regulated under FDA 510(k) clearance (K905802) with a Substantially Equivalent (SESE) determination, falling under the Powered Laser Surgical Instrument classification (GEX) for Class II devices. No specific MRI safety or sterility cycle details are provided in the regulatory data, though adherence to standard surgical instrument reprocessing protocols is implied. Authorised for use in the United States, it was submitted to the FDA in December 1990 and cleared in July 1991.
Other devices from Pfizer Laser Systems
Questions
AI-generated answers, 1 Oct 2026
What surgical procedures is the Centauri/Pegasus designed for?
The Centauri/Pegasus is specifically engineered for laser-based surgical procedures in general and plastic surgery. It delivers precise laser energy to perform controlled tissue ablation, coagulation, or vaporisation. The design minimizes thermal spread, which improves procedural accuracy and reduces collateral damage to surrounding tissues, making it suitable for delicate surgical applications.
Is the Centauri/Pegasus a single-use or reusable device?
The Centauri/Pegasus is supplied as a reusable medical device. It is intended for use in sterile surgical environments, meaning it must undergo proper reprocessing between procedures to maintain safety and sterility standards. While specific MRI safety or sterility cycle details are not provided, adherence to standard surgical instrument reprocessing protocols is implied.
What regulatory clearance does the Centauri/Pegasus hold?
The Centauri/Pegasus holds FDA 510(k) clearance under the classification of Powered Laser Surgical Instruments (product code GEX). It received a Substantially Equivalent (SESE) determination, confirming its compliance with regulatory standards for Class II devices. The device was submitted to the FDA in December 1990 and cleared in July 1991.
What types of tissue interventions can this laser instrument perform?
The Centauri/Pegasus is capable of performing three primary tissue interventions: ablation (removal of tissue), coagulation (sealing blood vessels), and vaporisation (evaporation of tissue). These functions are achieved through controlled laser energy delivery, ensuring precision and minimizing damage to adjacent tissues during surgical procedures.
Who is the manufacturer of the Centauri/Pegasus, and where is it based?
The Centauri/Pegasus is manufactured by Pfizer Laser Systems. The device was submitted to the FDA from their office located at 3 Morgan, Irvine, CA 92718, United States. This manufacturer specializes in laser surgical instruments for medical applications.