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E-TENG MODEL EOR 1

K122562 Class II Traditional
Decision Date
2013-08-09
Sponsor / Applicant
E-Teng Technology, Inc.

Technical Specification

510(k) Submission ID K122562
Product Code IPL
Medical Specialty / Panel Physical Medicine
Regulation Citation 21 CFR 890.3900
Decision Date 2013-08-09
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

E-TENG MODEL EOR 1 received FDA 510(k) clearance under submission number K122562, sponsored by E-Teng Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2013-08-09.

Classification & Regulation

This clearance is catalogued under FDA product code IPL and 21 CFR 890.3900, within the Physical Medicine review panel as a Class II device.