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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K260138
Device Name LUNE PureHygiene
Applicant
Enamel Pure
17 Briden St.
Worcester,  MA  01605
Applicant Contact Nathan Monty
Correspondent
Omnee Strategic Solutions, Inc.
7 Desrosiers Landing
South Grafton,  MA  01560
Correspondent Contact Dhaval Saraiya
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/16/2026
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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