TPLC - Total Product Life Cycle

• Device: laser, dental, soft tissue
• Regulation Description: Laser surgical instrument for use in general and plastic surgery and in dermatology.
• Definition: Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
• Product Code: NVK
• Regulation Number: 878.4810
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AZENA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BIOLASE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONVERGENT DENTAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
1.  K221761  Solea
DENTLIGHT, INC.
	SUBSTANTIALLY EQUIVALENT	1
EL.EN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	2
GIGAALASER COMPANY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MATELASER, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDENCY S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH.CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SOGA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUHAN PIOON TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Nerve Damage	1	1
Loss of Range of Motion	1	1
Numbness	1	1
Unspecified Heart Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Convergent Dental	II	Nov-17-2023