• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name laser, comb, hair
510(k) Number K192552
Device Name Irradiation Cosmetic Device
Chongqing Peninsula Medical Technology Co., Ltd.
No.2-4, 2F BLK1, Biological and Biochemical Park,
70-1 & 70-2# Ke Yuan 4 RD
Jiulongpo District,  CN 404100
Applicant Contact Zhang Sudi
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road,
Huangpu District
Guangzhou,  CN 51006
Correspondent Contact Cassie Lee
Regulation Number890.5500
Classification Product Code
Date Received09/17/2019
Decision Date 04/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No