CO2 Laser System (MBT- CO2 Laser)— 510(k) K262269
Substantially EquivalentBeijing Mega Beauty Technology Co., Ltd.
FDA 510(k) clearance K262269 for CO2 Laser System (MBT- CO2 Laser), Substantially Equivalent on 2026-09-01. Applicant: Beijing Mega Beauty Technology Co., Ltd.. Device class: 2.
Summary
CO2 Laser System (MBT- CO2 Laser) is from Beijing Mega Beauty Technology Co., Ltd., filed under product code GEX (Powered Laser Surgical Instrument). The record gives the model name and nothing else about the system.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Mega Beauty filed from Beijing, China. The decision came 57 calendar days after receipt (July 6 to September 1, 2026).
Clearance details
- Applicant
- Beijing Mega Beauty Technology Co., Ltd.
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code GEX
view allMore clearances from Beijing Mega Beauty Technology Co., Ltd.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.