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510(k) Data Aggregation
K Number
K243533Device Name
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
Manufacturer
HLB Co., Ltd. Healthcare
Date Cleared
2025-01-13
(59 days)
Product Code
FMK, ORK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
HLB Co., Ltd. Healthcare
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for capillary blood sampling.
Device Description
The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel devices housed in plastic, designed to puncture a fingertip for capillary blood sampling. They can be used anytime and anywhere to measure blood glucose levels in diabetic patients. The needle sleeve serves as a sterile barrier, sterilized to an SAL of 10-6 through irradiation. The product has a shelf life of 3 years.
The Sterilized Eol Auto Lancet includes a protective cap, handle, needle, button, lancing device, and two springs. To activate, simply remove the protective cap, place the button on the skin, and press the lancet. After use, the needle retracts into the device for safe handling.
The Sterilized Eol Lancet Plus includes a protective cap, handle, and needle. It can be used alone or with a lancing device that offers an adjustable tip and varying depth settings.
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