NUV · Massager, Vacuum, Light Induced Heating

General, Plastic Surgery · 3 clearances · 3 unique sponsors

Device class

Class II

Regulation 878.4810

Total clearances

2021-06-22 → 2026-08-28

Last 12 months

Unique sponsors

Definition

What is Massager, Vacuum, Light Induced Heating

The device is intended to temporarily alter the appearance of cellulite

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4810

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Players

Sponsor	Clearances	Last 12 mo	Most recent
B&M S.R.L. Marketing Nel Benessere	1	0	2023-09-22
I-Tech Industries Srl	1	0	2021-06-22
Zhengzhou PZ Laser Slim Technology Co., Ltd.	1	1	2026-08-28

Pulse

Date	K-number	Sponsor	Device
2026-08-28	K261582	Zhengzhou PZ Laser Slim Technology Co., Ltd.	Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
2023-09-22	K231092	B&M S.R.L. Marketing Nel Benessere	T-SHAPE 2
2021-06-22	K211272	I-Tech Industries Srl	ICOONE Laser Med (also referred to as ICOONE Medical laser)