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Data / Medical devices / Massager, Vacuum, Light Induced Heating

Massager, Vacuum, Light Induced Heating (NUV): 15 FDA-registered makers in 4 countries

15 establishments in 4 countries are registered with the FDA to make Massager, Vacuum, Light Induced Heating (product code NUV, Class 2, 21 CFR 878.4810). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on August 28, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
NUV
Device class
2
Regulation
878.4810
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
Israel6
United States5
Italy2
China2

Makers of Massager, Vacuum, Light Induced Heating

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Alma Lasers Ltd.CAESAREA Northern, IsraelManufacturer2January 21, 2011000api.fda.gov
Cynosure, LLCWestford, MA, United StatesComplaint file establishment, Manufacturer2April 2, 2010000api.fda.gov
I-Tech Industries SRLBologna, ItalyManufacturer2June 22, 2021000api.fda.gov
Preferred DepotIrvine, CA, United StatesRemanufacturer, Repackager or relabeler2June 22, 2021000api.fda.gov
B&M S.R.L.Milano, ItalyManufacturer1September 22, 2023000api.fda.gov
Beijing Honkon Technologies Co., Ltd.Beijing, ChinaManufacturer1March 2, 2017000api.fda.gov
Candela CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer1September 13, 2012000api.fda.gov
Inmode Ltd.Yokneam Northern, IsraelManufacturer1October 8, 2013000api.fda.gov
Viora Ltd.Migdal HaEmek Northern, IsraelManufacturer1July 1, 2009000api.fda.gov
World Aesthetix LLCJacksonville, FL, United StatesComplaint file establishment, Specification developer1March 2, 2017000api.fda.gov
Zhengzhou PZ Laser Slim Technology Co., LtdZhengzhou City Henan, ChinaManufacturer1August 28, 2026000api.fda.gov
B.Y. Medimor LtdTiberias Northern, IsraelContract manufacturer0000api.fda.gov
CogmedixWest Boylston, MA, United StatesContract manufacturer0000api.fda.gov
Sharplight Technologies Ltd.RISHON LEZION Tel Aviv, IsraelManufacturer0000api.fda.gov
Usr Electronic Systems (1987) LtdKarmiel Northern, IsraelContract manufacturer0000api.fda.gov

Updated August 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.