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U.S. Department of Health and Human Services

Product Classification

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Device powered light based non-laser surgical instrument with thermal effect
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl).Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic.Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.
Physical State The device comes in a wide verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavy with weight more than fifty pounds. It generally has a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions.
Technical Method This is a light based Non-Laser device that provides thermal effect including broad spectrum source devices such as Intense Pulse Light (IPL) that uses light energy to cut, destroy, remove or coagulate tissue, generally soft tissue. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Target Area The device generally targets skin (including dermis, epidermis) and underlying soft tissue or soft tissue in general.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeONF
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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