Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Light Based Over The Counter Wrinkle Reduction
510(k) Number K152332
Device Name Perfectio LED infrared device
Applicant
Omm Imports Inc Dba Zero Gravity
1945 S Ocean Dr. Apt.509 Hallandle Beach Blvd.
Hallandle,  FL  33009
Applicant Contact OHAD MENACHEM
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 1706, No 128 Songle Rd., Songjiang Area
Shanghai,  CN 201600
Correspondent Contact DORIS DONG
Regulation Number878.4810
Classification Product Code
OHS  
Date Received08/18/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-