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

TPLC - Total Product Life Cycle

  • 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 show TPLC since Back to Search Results
Device instrument for treatment of hyperhidrosis
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Soft-tissue coagulation
Product CodeOUB
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
MIRAMAR LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 376
Insufficient Information 10
Improper or Incorrect Procedure or Method 5
Complete Blockage 1
Use of Device Problem 1
Total Device Problems 393

Recalls
Manufacturer Recall Class Date Posted
1 Miramar Labs, Inc. II Nov-06-2015

-
-