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)

SMART TOUCH UVTHERAPY MULTIPLE MACHINE

K-Number: K110912 · 2011-10-20

ApplicantDaavlin Distributing Co.
Decision Date2011-10-20
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMART TOUCH UVTHERAPY MULTIPLE MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K110912. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART TOUCH UVTHERAPY MULTIPLE MACHINE?

SMART TOUCH UVTHERAPY MULTIPLE MACHINE is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K110912.

When did SMART TOUCH UVTHERAPY MULTIPLE MACHINE receive FDA 510(k) clearance?

SMART TOUCH UVTHERAPY MULTIPLE MACHINE received FDA 510(k) clearance on 2011-10-20, under 510(k) number K110912.

Who is the listed applicant for SMART TOUCH UVTHERAPY MULTIPLE MACHINE?

The FDA 510(k) record lists Daavlin Distributing Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART TOUCH UVTHERAPY MULTIPLE MACHINE?

The FDA product code for SMART TOUCH UVTHERAPY MULTIPLE MACHINE is FTC.

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 Daavlin Distributing Co. 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.

K233811DT Controlled Phototherapy EquipmentK2303823 Series NeoLuxK2208401 Series Phototherapy EquipmentK2125107 Series Phototherapy DeviceK210881M Series Phototherapy EquipmentK1111724 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES

View all 14 devices →

Related Devices (Code: FTC)

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.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech 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.

↑