DropSafe Acti-Lance Safety Lancets; Droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; Droplet MEDLANCE PLUS Safety Lancets, DropSafe ErgoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lan

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

HTL-Strefa S.A.

The following data is part of a premarket notification filed by Htl-strefa S.a. with the FDA for Dropsafe Acti-lance Safety Lancets; Droplet Acti-lance Safety Lancets, Dropsafe Medlance Plus Safety Lancets; Droplet Medlance Plus Safety Lancets, Dropsafe Ergolance Safety Lancets, Dropsafe Prolance Safety Lancets, Dropsafe Medisafe Solo Safety Lan.

Pre-market Notification Details

• Device ID: K220643
• 510k Number: K220643
• Device Name: DropSafe Acti-Lance Safety Lancets; Droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; Droplet MEDLANCE PLUS Safety Lancets, DropSafe ErgoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lan
• Classification: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
• Applicant: HTL-Strefa S.A. Adamowek 7 Ozorkow, PL 95-035
• Contact: Justyna Zemigala
• Correspondent: Justyna Zemigala; HTL-Strefa S.A. Adamowek 7 Ozorkow, PL 95-035
• Product Code: FMK
• CFR Regulation Number: 878.4850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-03-04
• Decision Date: 2022-07-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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