FDA 510(k) Premarket Notification K192521: Intense Pulsed Light Treatment System

Submission Details & Decision

Normalized public record details for 510(k) notification K192521.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K192521

Applicant / Sponsor

Shangdong Huamei Technology Co., Ltd.

Device Name

Intense Pulsed Light Treatment System

Product Code

ONF

Decision Date

2019-12-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Traditional

Third Party Flag

Date Received

2019-09-13

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