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FDA 510(k)

Intensity Pulsed Light Therapy System

K-Number: K233307 · 2024-03-15

ApplicantBeijing Adss Development Co., Ltd.
Decision Date2024-03-15
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intensity Pulsed Light Therapy System is a medical device manufactured by Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2024-03-15 under approval number K233307. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intensity Pulsed Light Therapy System?

Intensity Pulsed Light Therapy System is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Beijing Adss Development Co., Ltd.. The 510(k) number is K233307.

When was Intensity Pulsed Light Therapy System approved by the FDA?

Intensity Pulsed Light Therapy System received FDA 510(k) clearance on 2024-03-15, under approval number K233307.

What company makes Intensity Pulsed Light Therapy System?

Intensity Pulsed Light Therapy System is manufactured by Beijing Adss Development Co., Ltd..

What is the FDA product code for Intensity Pulsed Light Therapy System?

The FDA product code for Intensity Pulsed Light Therapy System is ONF.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Beijing Adss Development Co., Ltd.

K161692Diode Laser Therapy Machine K161925CO2 Laser Therapy Machine K161286IPL Therapy Machine K161926ND YAG Q-switch Laser Therapy Machine K192295PDT-FACE K220268Picosecond Laser System (Model PS10-A and PS10-B)

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Related Devices (Code: ONF)

K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd K161286IPL Therapy MachineBeijing Adss Development Co., Ltd. K160195Forma System, Forma Light SystemFormatk Systems , Ltd. K153717Venus Versa SystemVenus Concept , Ltd. K152790Venus Versa SystemVenus Concept , Ltd. K181868SHINY RPL SystemIds, 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.

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