meddevicedb.com FDA Device Reference

Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)

K243306 Class II Special
Decision Date
2024-11-15
Sponsor / Applicant
Tianjin Huahong Technology Co., Ltd.

Technical Specification

510(k) Submission ID K243306
Product Code QRL
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4850
Decision Date 2024-11-15
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) received FDA 510(k) clearance under submission number K243306, sponsored by Tianjin Huahong Technology Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-11-15.

Classification & Regulation

This clearance is catalogued under FDA product code QRL and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.