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)

HEATLUX

K-Number: K120582 · 2012-07-06

ApplicantHome Skinovations , Ltd.
Decision Date2012-07-06
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEATLUX is the device name listed in this FDA 510(k) record. The listed applicant is Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2012-07-06 under 510(k) number K120582. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEATLUX?

HEATLUX is a medical device that received FDA 510(k) clearance on 2012-07-06. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K120582.

When did HEATLUX receive FDA 510(k) clearance?

HEATLUX received FDA 510(k) clearance on 2012-07-06, under 510(k) number K120582.

Who is the listed applicant for HEATLUX?

The FDA 510(k) record lists Home Skinovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEATLUX?

The FDA product code for HEATLUX is ILY.

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 Home Skinovations , Ltd. 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.

K214078Silk’n ToothwaveK180279Silk'n MODEL H5003 deviceK171433Silk'n InfinityK162784Silk'n HSTK152087HeatLux Pro IIK131870GLIDE DEVICE

View all 12 devices →

Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

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.

↑