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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K260157
Device Name LifeLens Physiological Monitor
Applicant
LifeLens Technologies, Inc.
1 Ivybrook Blvd.
Suite 100
Ivyland,  PA  18974
Applicant Contact Matthew Walenciak
Correspondent
MEDIcept, Inc.
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact Endri Angjeli
Regulation Number870.2800
Classification Product Code
DSH  
Subsequent Product Codes
BZQ   DQA   DRG   FLL  
Date Received01/20/2026
Decision Date 07/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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