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FDA 510(k)

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

K-Number: K242595 · 2024-11-07

ApplicantShenzhen Greatro Electronic Technology Co., Ltd.
Decision Date2024-11-07
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is a medical device manufactured by Shenzhen Greatro Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-07 under approval number K242595. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is a medical device that received FDA 510(k) clearance on 2024-11-07. It is manufactured by Shenzhen Greatro Electronic Technology Co., Ltd.. The 510(k) number is K242595.

When was Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) approved by the FDA?

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) received FDA 510(k) clearance on 2024-11-07, under approval number K242595.

What company makes Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is manufactured by Shenzhen Greatro Electronic Technology Co., Ltd..

What is the FDA product code for Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

The FDA product code for Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is OHT.

Related Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07599709 LONG PULSED ND:YAG LASER (1064 NM) VERSUS INTENSE PULSED LIGHT IN TREATMENT OF TRAUMATIC AND POST-SURGICAL ERYTHEMATOUS SCARS COMPLETED NCT06432881 Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE) RECRUITING NCT06063148 Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation ACTIVE_NOT_RECRUITING NCT07571486 Therapeutic Approach of Repeated Transient Blood-brain Barrier Opening in Amyotrophic Lateral Sclerosis. NOT_YET_RECRUITING NCT06922812 IWLS for Major Depressive Disorder: An Open-Label Study of Safety, Tolerability, and Efficacy ACTIVE_NOT_RECRUITING

Other Devices by Shenzhen Greatro Electronic Technology Co., Ltd.

K232932Intense Pulse Light Therapeutic Apparatus

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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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