Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NUFACE, MODEL NU-4003

K-Number: K072260 · 2007-11-27

ApplicantCarol Cole Company
Decision Date2007-11-27
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NUFACE, MODEL NU-4003 is the device name listed in this FDA 510(k) record. The listed applicant is Carol Cole Company. It received FDA 510(k) clearance on 2007-11-27 under 510(k) number K072260. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUFACE, MODEL NU-4003?

NUFACE, MODEL NU-4003 is a medical device that received FDA 510(k) clearance on 2007-11-27. The listed applicant is Carol Cole Company. The 510(k) number is K072260.

When did NUFACE, MODEL NU-4003 receive FDA 510(k) clearance?

NUFACE, MODEL NU-4003 received FDA 510(k) clearance on 2007-11-27, under 510(k) number K072260.

Who is the listed applicant for NUFACE, MODEL NU-4003?

The FDA 510(k) record lists Carol Cole Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUFACE, MODEL NU-4003?

The FDA product code for NUFACE, MODEL NU-4003 is NFO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Carol Cole Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161654NuFACE Gel PrimerK131251TRINITY ELEK120560TRINITY WRINKLE REMOVERK103472NUFACE PLUS

Related Devices (Code: NFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.K262861PureLift Pro MaxXtreem Pulse, LLCK260387SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)Hironic Co., Ltd.K253932FACEGYM Pro Device (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑