510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NUVClass II

Massager, Vacuum, Light Induced Heating

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

NUV is the FDA product code for Massager, Vacuum, Light Induced Heating, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "The device is intended to temporarily alter the appearance of cellulite". As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NUV
Device name
Massager, Vacuum, Light Induced Heating
FDA definition
The device is intended to temporarily alter the appearance of cellulite
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
20
Ingested recalls
0

Clearances, product code NUV

By decision year
20 clearances under product code NUV with a decision year between 2005 and 2026, 2009 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NUV by decision year
YearClearances
20051
20062
20072
20081
20094
20102
20111
20121
20131
20171
20191
20211
20231
20261

Applicants with the most clearances

Product code NUV
Applicants holding the most 510(k) clearances under product code NUV
ApplicantClearances
Syneron Medical, Ltd.4
Alma Lasers Ltd.2
Cutera Inc2
Eleme Medical, Inc.2
I-Tech Industries SRL2
B&M S.r.l. Marketing Nel Benessere1
Beijing Honkon Technologies Co., Ltd.1
Bicellulase, Inc.1
Biocellulase, Inc.1
Chromogenex Technologies Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order