510(k) clearance

Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)

FDA 510(k) source

510(k) number

K262822

Applicant

Zhongshan GL Electronics Co. , Ltd.

Decision date

Oct 7, 2026

Date received

Aug 10, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

BTA

Device type

Pump, Portable, Aspiration (Manual Or Powered)

Device class

Class II

Regulation

21 CFR 878.4780

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Zhongshan, CN