Identifiers
- 510(k) Number
- K864336 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pachymeter System V is a diagnostic ultrasound device classified as a pachymeter (perimeter thickness measurement instrument) under the FDA’s radiology category. It measures corneal thickness, a critical parameter in assessing ocular health, diagnosing conditions such as glaucoma, and guiding surgical interventions like corneal transplants or refractive procedures.
This system is supplied as a reusable medical device and is intended for use in clinical radiology settings. It requires FDA 510(k) clearance (K864336) and was authorized under the Traditional pathway, with a decision date of January 9, 1987. The device is not labeled as MRI-safe or sterile; its specifications do not include single-use or disposable variants, and storage conditions are not detailed in the regulatory submission.
Frequently asked questions
What clinical conditions is the Pachymeter System V primarily used to assess in patients?
The Pachymeter System V measures corneal thickness, which is essential for diagnosing conditions like glaucoma and evaluating patients before procedures such as corneal transplants or refractive surgeries. Accurate corneal thickness readings help clinicians assess ocular health and plan treatments.
Is the Pachymeter System V designed for single-use, or is it meant to be reused in a clinical setting?
The Pachymeter System V is explicitly described as a reusable medical device, intended for use in clinical radiology settings. It is not labeled as a single-use or disposable variant, so proper cleaning and maintenance are required between patient uses.
How is the Pachymeter System V authorized for use in the United States?
The device received FDA clearance through the 510(k) pathway, specifically under the Traditional route, with the clearance number K864336. It was determined to be substantially equivalent to a predicate device and authorized on January 9, 1987, for measuring corneal thickness in radiology settings.
What type of environment is the Pachymeter System V intended for, and are there any special storage requirements mentioned?
The device is intended for use in clinical radiology settings, but the regulatory submission does not specify detailed storage conditions. Since it is reusable and not labeled as sterile, proper handling and maintenance protocols should be followed to ensure accuracy and longevity.
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: PACHYMETER SYSTEM V (K864336) — FDA 510(k) | Innolitics, PDF K864336 PACHYMETER SYSTEM V - 510kdatabase.net, CooperVision Pachymeter - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K864336 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K864336 24 fields · synced Sep 19, 2026