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 laser, comb, hair
510(k) Number K181308
Device Name SuperGrow 272, Ultimate 272
Applicant
Super Grow Lasers
1903 Commonwealth Street #16
Houston,  TX  77006
Applicant Contact Jeffrey Stanifer
Correspondent
AcKnowledge Regulatory Strategies, LLC
2834 Hawthorn Street
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number890.5500
Classification Product Code
OAP  
Date Received05/17/2018
Decision Date 08/15/2018
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
-
-