808nm semiconductor laser hair removal machine— 510(k) K252048
Substantially EquivalentXi'An Taibo Electronic Technology Co., Ltd.
FDA 510(k) clearance K252048 for 808nm semiconductor laser hair removal machine, Substantially Equivalent on 2026-02-03. Applicant: Xi'An Taibo Electronic Technology Co., Ltd.. Device class: 2.
Summary
Xi'An Taibo Electronic Technology filed an 808nm semiconductor laser hair removal machine under product code GEX, powered laser surgical instrument. The name is descriptive, and the record gives no model number or brand.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Xi'An Taibo Electronic Technology filed from Xi'An, China. Review took 218 calendar days (June 30, 2025 to February 3, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Xi'An Taibo Electronic 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
- Xi'An, CN
Recent devices under product code GEX
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.