Identifiers
- 510(k) Number
- K834159 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)
The Phacotron Plus is a phacoemulsification unit, a device classified under the nomenclature for phacoemulsifiers and aspirators (Unit, Phacofragmentation). It is designed for ophthalmic surgery to emulsify and aspirate cataracts from the eye using ultrasonic energy, facilitating lens removal and subsequent intraocular lens implantation.
The Phacotron Plus is a reusable Class II device (device class 2) used in operating rooms for cataract surgery. It is authorized under FDA 510(k) clearance (K834159) and adheres to regulatory standards for ophthalmic surgical equipment. The device is not specified as MRI-safe and requires proper sterilization and maintenance between uses. It is governed by the FDA regulation number 886.4670 and falls under the product code HQC.
Phacotron Plus
Frequently asked questions
What is the Phacotron Plus used for?
The Phacotron Plus is a phacoemulsification unit designed for ophthalmic surgery to emulsify and aspirate cataracts from the eye using ultrasonic energy, facilitating lens removal and subsequent intraocular lens implantation.
Is the Phacotron Plus a single-use or reusable device?
The Phacotron Plus is a reusable Class II device that requires proper sterilization and maintenance between uses. It is designed for multiple applications in operating room settings for cataract surgery.
What regulatory approvals does the Phacotron Plus have?
The Phacotron Plus is authorized under FDA 510(k) clearance (K834159) and is classified under the product code HQC. It is governed by FDA regulation number 886.4670 and is not specified as MRI-safe.
How is the Phacotron Plus supplied and stored?
The device is supplied as a reusable unit that requires proper sterilization between uses. Specific storage requirements are not detailed in the provided information, but as a medical device, it should be stored according to manufacturer guidelines in a clean, controlled environment.
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: PHACOTRON PLUS 510 (k) K834159 - FDA.report, American Surgical Company, American Surgical Co Inc FDA Filings, American Surgical… — 9 FDA 510 (k)s · DeviceClearance, Phacotron Systems Plus Iii Phacoemulsifier Aspi.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K834159 | Class II | Active |
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Manufacturer
- Manufacturer
- American Surgical Company, LLC
- FDA Applicant
- American Surgical Co., Inc.
Sources (1)
- FDA 510(k) K834159 24 fields · synced Oct 6, 2026