CO2 Laser Therapy System
K-Number: K192528 · 2019-12-03
Device Summary
Frequently Asked Questions
What is the CO2 Laser Therapy System?
CO2 Laser Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K192528.
When did CO2 Laser Therapy System receive FDA 510(k) clearance?
CO2 Laser Therapy System received FDA 510(k) clearance on 2019-12-03, under 510(k) number K192528.
Who is the listed applicant for CO2 Laser Therapy System?
The FDA 510(k) record lists Shangdong Huamei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CO2 Laser Therapy System?
The FDA product code for CO2 Laser Therapy System is GEX. This falls under the Gastroenterology category.
Other records listing Shangdong Huamei 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: 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.
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.