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510(k) K211150

Dental diode laser, SOGA Laser, ILaser II by Shenzhen Soga Technology Co., Ltd. — Product Code NVK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2022
Date Received
April 19, 2021
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Dental, Soft Tissue
Device Class
Class II
Regulation Number
878.4810
Review Panel
DE
Submission Type

Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

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