Standard Ultrasonic Handpiece
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K940088 FDA 510(k)
- FDA Product Code
- HQC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4670 FDA 510(k)
- Regulation Number
- 886.4670 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Unit, Phacofragmentation system designed for ophthalmic use, specifically for cataract surgery. It employs ultrasound technology to fragment and emulsify cataracts, facilitating their removal via a fragmenting needle powered by alternating current (AC).
The Standard Ultrasonic Handpiece is supplied as a reusable medical instrument, intended for use in controlled surgical environments. It is classified as a Class II device under FDA regulations (21 CFR 886.4670) and holds a 510(k) clearance (K940088) for ophthalmic applications. No MRI safety or sterility specifications are explicitly stated in the provided data.
Frequently asked questions
What is the primary clinical use of the Standard Ultrasonic Handpiece, and how does it function during cataract surgery?
The Standard Ultrasonic Handpiece is designed specifically for ophthalmic use in cataract surgery. It employs ultrasound technology to fragment and emulsify cataracts, allowing for their removal via a fragmenting needle powered by alternating current (AC). This process helps break down the clouded lens into smaller pieces that can be safely aspirated from the eye.
Is this device single-use or reusable, and what are the implications for maintenance and sterilization?
The Standard Ultrasonic Handpiece is supplied as a reusable medical instrument, intended for use in controlled surgical environments. Since it is reusable, proper cleaning, maintenance, and sterilization protocols must be followed between uses to ensure patient safety and device functionality. The provided data does not specify sterilization methods, so facility-specific guidelines should be consulted.
What regulatory pathway was followed for FDA clearance, and what does the product code HQC indicate?
The device received FDA clearance through a 510(k) submission (K940088), classified as a Class II medical device under 21 CFR 886.4670. The product code HQC corresponds to the ophthalmic surgical instruments category, confirming its intended use in eye surgery procedures. The clearance was granted under the Traditional 510(k) Review pathway, with the Ophthalmic Devices Panel (OP) as the advisory committee.
Are there multiple models or variations of this handpiece, and how can I identify the correct one for my procedure?
The provided data lists multiple FEI (Facility Establishment Identifier) numbers, which indicate that this device has been registered under various facility identifiers across different locations. While these do not represent distinct models, they confirm widespread use in ophthalmic settings. The device itself is described as a Standard Ultrasonic Handpiece, so compatibility should be verified with your surgical system’s specifications. Consult the manufacturer or your facility’s inventory records to confirm the exact model in use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medical Technical Products Standard Ultrasonic Handpiece, Medical Technical Products, 510 (k) Premarket Notification, Medical Technical Products - medtechprods.com, US Handpiece, Standard — FDA Class II Medical Device | MedEquip Directory
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K940088 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Technical Products
Sources (1)
- FDA 510(k) K940088 24 fields · synced Sep 19, 2026