Microlet Next Lancing Device, Microlet Lancet
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220633 FDA 510(k)
- FDA Product Code
- QRL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Microlet Next lancing device is a multiple use blood lancet for single patient use only, classified as a Class II medical device. It is designed for blood glucose testing and provides customizable depth settings from 1.25 mm to 2.75 mm with smooth glide technology for comfort and control during use.
The device is intended for use with Microlet silicone-coated lancets and features one-handed ejection for safe disposal. It is supplied non-sterile and is reusable by a single patient. Regulatory authorization is based on FDA 510(k) clearance (K220633) under regulation number 878.4850, with product code QRL.
Frequently asked questions
What is the Microlet Next lancing device used for?
The Microlet Next lancing device is designed for blood glucose testing, providing customizable depth settings from 1.25 mm to 2.75 mm with smooth glide technology for comfort and control during use.
Is the Microlet Next lancing device sterile or non-sterile when supplied?
The device is supplied non-sterile and is intended for reuse by a single patient only, as it is classified as a multiple use blood lancet for single patient use only.
What type of lancets are compatible with the Microlet Next lancing device?
The Microlet Next lancing device is intended for use with Microlet silicone-coated lancets and features one-handed ejection for safe disposal after use.
How is the Microlet Next lancing device regulated and authorized?
The device has FDA 510(k) clearance (K220633) under regulation number 878.4850, with product code QRL, and is classified as a Class II medical device based on substantial equivalence.
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: Stechhilfe & Lanzetten | MICROLET®NEXT, MICROLET®NEXT Lancing Device | Lancet Pen | CONTOUR® - Ascensia Diabetes, The MICROLET NEXT lancing device - HCP | Ascensia Diabetes Care, Stechhilfe & Lanzetten | MICROLET®NEXT, Ascensia MICROLET NEXT Adjustable 5 Depths Lancing Device for Diabetes
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220633 | Class II | Active |
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Manufacturer
- Manufacturer
- Ascensia Diabetes Care U.S., Inc.
Sources (1)
- FDA 510(k) K220633 24 fields · synced Oct 6, 2026