PachPen Pachymeter, Model 24-5100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050552 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 PachPen Pachymeter is a handheld device used for measuring corneal thickness. It features an ergonomic design for comfortable handling and incorporates Digital Signal Analysis to eliminate non-perpendicular measurements on the cornea.
The device is supplied as a handheld unit and is intended for use in ophthalmic settings. It is authorized under FDA 510K clearance with K number K050552 and product code IYO. The device is designed for single-use applications and should be stored according to manufacturer guidelines.
Frequently asked questions
What is the PachPen Pachymeter used for?
The PachPen Pachymeter is a handheld device designed for measuring corneal thickness in ophthalmic settings. It features an ergonomic design and Digital Signal Analysis to eliminate non-perpendicular measurements on the cornea.
Is the PachPen Pachymeter single-use or reusable?
The PachPen Pachymeter is designed for single-use applications. After use, it should be disposed of according to medical waste guidelines and stored according to manufacturer guidelines when not in use.
What regulatory approvals does the PachPen Pachymeter have?
The PachPen Pachymeter is authorized under FDA 510K clearance with K number K050552 and product code IYO. It has been determined to be substantially equivalent to predicate devices.
How is the PachPen Pachymeter supplied?
The device is supplied as a handheld unit intended for use in ophthalmic settings. It comes ready for use with no additional assembly required, though specific packaging contents may vary.
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: PachPen Handheld Pachymeter - Keeler USA, PachPen Handheld Pachymeter - Keeler PachPen Pachymeter, PDF PachPen Handheld Pachymeter - opimed.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050552 | Class II | Active |
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Manufacturer
- Manufacturer
- Accutome, Inc.
Sources (1)
- FDA 510(k) K050552 24 fields · synced Sep 24, 2026