TPLC - Total Product Life Cycle

• Device: light based over the counter wrinkle reduction
• Regulation Description: Laser surgical instrument for use in general and plastic surgery and in dermatology.
• Definition: Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
• Product Code: OHS
• Regulation Number: 878.4810
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESTHETIC TECHNOLOGY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ATOP LIGHTING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEMER INT AG
	SUBSTANTIALLY EQUIVALENT	1
CAROL COLE COMPANY DBA NUFACE
	SUBSTANTIALLY EQUIVALENT	1
CELLRETURN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DERMAL PHOTONICS CORP
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN BOYUAN INTELLIGENT TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN HUNTER ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN LAIGUANG ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN YANXI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN YIJIAMING TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DUPLEX INTERNATIONAL TRADING LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FOREO, INC.
	SUBSTANTIALLY EQUIVALENT	3
FOSHAN GUANGYU WEILAI MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG ACE-TEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG NEWDERMO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
GUANGZHOU AHEAD INTELLIGENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEAT IN A CLICK, LLC
	SUBSTANTIALLY EQUIVALENT	2
HUNAN GUANGYE BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ISMART DEVELOPMENTS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
LED INTELLECTUAL PROPERTIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
LED TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
LIGHT TREE VENTURES EUROPE B.V.
	SUBSTANTIALLY EQUIVALENT	7
LYMA LIFE , LTD.
	SUBSTANTIALLY EQUIVALENT	2
MERCHSOURCE, LLC
	SUBSTANTIALLY EQUIVALENT	2
MYBLEND
	SUBSTANTIALLY EQUIVALENT	1
NINGBO HESI ELECTRIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NOOANCE
	SUBSTANTIALLY EQUIVALENT	1
PREMIER NORTH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHARKNINJA OPERATING, LLC
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN AOZEMEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN BORRIA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DACHI COMMUNICATION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DESIDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN FITTOP HEALTH TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN GOODWIND TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HANHUA OPTO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN IDEA LIGHT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JIANCHAO INTELLIGENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN KAIYAN MEDICAL CO , LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	15
SHENZHEN LIYOUTONG TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN NUON MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN PERFECT IDEA TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN QIANYU TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN RAINBOW TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN SAIDI LIGHT THERAPY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN SUNGPO HI-TECH ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SUNGROW LED TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SUNSRED TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ULIKE SMART ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHENZHEN WALTON TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XINLONG PRECISION PLASTIC MOLD PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ZHENXING RUITONG TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STG24 CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUNGLOR TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SZ KKS SILICONE&ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TERMOSALUD S.L.
	SUBSTANTIALLY EQUIVALENT	1
THE BEAUTY TECH GROUP, LTD.
	SUBSTANTIALLY EQUIVALENT	1
THERABODY, INC.
	SUBSTANTIALLY EQUIVALENT	1
THERAGUN, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XPLR , LTD.
	SUBSTANTIALLY EQUIVALENT	1
Y & J BIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
YRS GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2021	2	2
2022	2	2
2023	4	4
2024	5	5
2025	37	37
2026	35	35

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Device Problem Information	39	39
Patient Device Interaction Problem	18	18
Adverse Event Without Identified Device or Use Problem	3	3
Patient-Device Incompatibility	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	34	34
Skin Discoloration	25	25
Erythema	22	22
Skin Burning Sensation	17	17
Eye Irritation	12	12
Swelling/ Edema	11	11
Pain	10	10
Hypersensitivity/Allergic reaction	10	10
Burn(s)	9	9
Dry Skin	9	9
Blister	7	7
Burning Sensation	5	5
Rash	5	5
Peeling	3	3
Ecchymosis	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Superficial (First Degree) Burn	3	3
Headache	2	2
Inflammation	2	2
Epistaxis	2	2
Wrinkling	2	2
Physical Asymmetry	2	2
Scar Tissue	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Itching Sensation	2	2
Insufficient Information	2	2
Red Eye(s)	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Paresthesia	1	1
Dizziness	1	1
Hyperresponsive to stimuli	1	1
Blurred Vision	1	1
Eye Pain	1	1
Numbness	1	1
Visual Impairment	1	1
Skin Erosion	1	1
Contact Dermatitis	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Corneal Abrasion	1	1
Electric Shock	1	1
Twitching	1	1
Viral Infection	1	1
Eye Burn	1	1
Ear infection	1	1
Conjunctivitis	1	1
Bruise/Contusion	1	1
Dry Eye(s)	1	1