Identifiers
- 510(k) Number
- K172818 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LMT-3000 is a laser lancing device designed for peripheral blood sampling. It employs laser technology to create precise skin incisions, enabling rapid and minimally invasive blood collection without the need for traditional lancets. This method reduces patient discomfort and lowers the risk of secondary infection compared to conventional methods. The device is classified under the product code GEX, indicating its use in general plastic surgery applications.
The LMT-3000 is supplied as a single-use, non-sterile device intended for use in clinical settings where blood sampling is required. It is compatible with diagnostic devices and can be operated with a power-on/off function. The device has received FDA 510(k) clearance under the Traditional review pathway, demonstrating its regulatory compliance for use in the United States. Storage and handling instructions are not specified in the provided data, but standard medical device precautions should be followed.
Frequently asked questions
What is the LMT-3000 laser lancing device used for?
The LMT-3000 is designed specifically for peripheral blood sampling. It employs laser technology to create precise skin incisions, allowing for rapid and minimally invasive blood collection. This method is particularly useful in clinical settings where traditional lancets may cause more discomfort or increase infection risk.
Is the LMT-3000 device single-use or reusable?
The LMT-3000 is supplied as a single-use device. This ensures patient safety and hygiene, as each device is intended for one-time use only, reducing the risk of cross-contamination between patients.
What are the sterility and compatibility details for the LMT-3000?
The LMT-3000 is classified as a non-sterile device. While it is intended for clinical use, it is compatible with standard diagnostic devices used for blood sampling. Always follow proper clinical protocols to ensure safe and accurate blood collection.
How does the LMT-3000 differ from traditional lancets in terms of patient experience?
Unlike traditional lancets, the LMT-3000 uses laser technology to create precise incisions, which typically results in less patient discomfort and a quicker recovery time. The method also reduces the risk of secondary infection, making it a more advanced option for blood sampling.
What regulatory pathway has the LMT-3000 followed for FDA clearance?
The LMT-3000 has received FDA 510(k) clearance under the Traditional review pathway. This clearance demonstrates that the device meets regulatory standards for safety and effectiveness in the United States, ensuring its compliance with medical device regulations.
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: HandyRay (LMT-3000) - LaMeditech - PDF Catalogs | Technical Documentation, Laser Lancing Device - Korean-Electronics.com, Lameditech - Instagram, K172818 FDA 510 (k) - LMT-3000 | Lameditech Co. , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172818 | Class II | Active |
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Manufacturer
- Manufacturer
- Lameditech Co., Ltd.
- FDA Applicant
- Lameditech Co. , Ltd.
Sources (1)
- FDA 510(k) K172818 24 fields · synced Oct 1, 2026