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FDA 510(k)

Intense Pulse Light Therapeutic Apparatus

K-Number: K232932 · 2023-12-04

Decision Date2023-12-04
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulse Light Therapeutic Apparatus is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Greatro Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-04 under 510(k) 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. The listed applicant is Shenzhen Greatro Electronic Technology Co., Ltd.. The 510(k) number is K232932.

When did Intense Pulse Light Therapeutic Apparatus receive FDA 510(k) clearance?

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

Who is the listed applicant for Intense Pulse Light Therapeutic Apparatus?

The FDA 510(k) record lists Shenzhen Greatro Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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.

Other records listing Shenzhen Greatro Electronic Technology Co., 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.

Related Devices (Code: OHT)

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.

Official Source

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