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FDA 510(k)

Phototherapy System (OL-PDT950)

K-Number: K230342 · 2023-08-16

ApplicantShanghai Omni Laser Skinology Co., Ltd.
Decision Date2023-08-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Phototherapy System (OL-PDT950) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Omni Laser Skinology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K230342. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phototherapy System (OL-PDT950)?

Phototherapy System (OL-PDT950) is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Shanghai Omni Laser Skinology Co., Ltd.. The 510(k) number is K230342.

When did Phototherapy System (OL-PDT950) receive FDA 510(k) clearance?

Phototherapy System (OL-PDT950) received FDA 510(k) clearance on 2023-08-16, under 510(k) number K230342.

Who is the listed applicant for Phototherapy System (OL-PDT950)?

The FDA 510(k) record lists Shanghai Omni Laser Skinology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phototherapy System (OL-PDT950)?

The FDA product code for Phototherapy System (OL-PDT950) is GEX. This falls under the Gastroenterology category.

Other records listing Shanghai Omni Laser Skinology Co., Ltd. as applicant

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Related Devices (Code: GEX)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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