Phacotron Gold Multifunction Ultrasonic Handpiece
510(k) K925631
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925631 | Date29 Jul 1993 | 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- Withdrawn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
- HQC
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4670
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Phacotron Gold Multifunction Ultrasonic Handpiece is a phacofragmentation device (Unit, Phacofragmentation) designed for ophthalmic surgery. It employs ultrasonic energy to emulsify and remove cataracts or other intraocular tissues, facilitating precise lens fragmentation during cataract extraction procedures. Its multifunction capability allows versatility in handling various surgical requirements within the same handpiece.
This device is supplied as a reusable medical instrument, intended for use in sterile operating room environments. It is classified as a Class II device under FDA regulations (886.4670) and has received FDA 510(k) clearance (K925631) as substantially equivalent to a predicate device. Multiple model variants are listed under the product code HQC, with no specific MRI safety or sterility requirements stated beyond standard surgical protocols. Storage and handling follow typical aseptic techniques for reusable surgical instruments.
Other devices from Chiron Intraoptics
Questions
AI-generated answers, 1 Oct 2026
What is the Phacotron Gold Multifunction Ultrasonic Handpiece used for?
The Phacotron Gold Multifunction Ultrasonic Handpiece is designed specifically for phacofragmentation during cataract surgery. It uses ultrasonic energy to emulsify and remove cataracts or other intraocular tissues, enabling precise fragmentation of the lens. Its multifunction capability allows it to adapt to various surgical requirements within the same handpiece, enhancing versatility in the operating room.
Is the Phacotron Gold Multifunction Ultrasonic Handpiece reusable or single-use?
The Phacotron Gold Multifunction Ultrasonic Handpiece is supplied as a reusable medical instrument. Like other reusable surgical tools, it must be sterilized and maintained according to standard aseptic techniques for operating room environments to ensure safety and efficacy between uses.
What are the key specifications or model variants of this device?
The Phacotron Gold Multifunction Ultrasonic Handpiece is listed under the FDA product code HQC and includes multiple model variants, each identified by a unique FEI number (e.g., 1000120314, 3006695864). These variants are intended for use in ophthalmic surgery and are classified under the medical specialty description 'Ophthalmic.' No specific MRI safety or sterility requirements beyond standard surgical protocols are mentioned.
How should the Phacotron Gold Multifunction Ultrasonic Handpiece be stored?
The device should be stored following typical aseptic techniques for reusable surgical instruments. This includes maintaining cleanliness, protecting it from contamination, and adhering to manufacturer guidelines for storage conditions to preserve its functionality and sterility until use in a sterile operating room environment.
What regulatory clearance does the Phacotron Gold Multifunction Ultrasonic Handpiece hold?
The Phacotron Gold Multifunction Ultrasonic Handpiece has received FDA 510(k) clearance (K925631) as substantially equivalent to a predicate device. It is classified as a Class II device under FDA regulations (886.4670) and is intended for use in ophthalmic surgery as a phacofragmentation tool.