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FDA 510(k)

Intense Pulse Light Therapeutic Apparatus

K-Number: K232932 · 2023-12-04

ApplicantShenzhen Greatro Electronic Technology Co., Ltd.
Decision Date2023-12-04
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulse Light Therapeutic Apparatus is a medical device manufactured by Shenzhen Greatro Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-04 under approval number K232932. 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?

Intense Pulse Light Therapeutic Apparatus is a medical device that received FDA 510(k) clearance on 2023-12-04. It is manufactured by Shenzhen Greatro Electronic Technology Co., Ltd.. The 510(k) number is K232932.

When was Intense Pulse Light Therapeutic Apparatus approved by the FDA?

Intense Pulse Light Therapeutic Apparatus received FDA 510(k) clearance on 2023-12-04, under approval number K232932.

What company makes Intense Pulse Light Therapeutic Apparatus?

Intense Pulse Light Therapeutic Apparatus is manufactured by Shenzhen Greatro Electronic Technology Co., Ltd..

What is the FDA product code for Intense Pulse Light Therapeutic Apparatus?

The FDA product code for Intense Pulse Light Therapeutic Apparatus 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.

K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

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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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