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

MAUDE Adverse Event Report: SHASER, INC LUMARX; LIGHT BASED HAIR REMOVAL DEVICE
  • 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
 

SHASER, INC LUMARX; LIGHT BASED HAIR REMOVAL DEVICE Back to Search Results
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problems Scarring (2061); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Type  Injury  
Event Description
(b)(4).
 
Manufacturer Narrative
Indication for use: removal of unwanted body and/or facial hair in adults with fitzpatrick skin types 1-4.User experienced what is likely permanent damage/scarring to her skin.User claims first and second degree burns have been diagnosed, although after several attempts, no medical records have been provided to confirm.Upon review of pictures provided by the user, it was clear that the user should not have passed the skin tone sensor which is a failsafe in the design that would turn the device off if skin tone was too dark.Additionally, skin tone charts are provided throughout the labeling and packaging of the device that would indicate that this person was too dark to use device.Although there was no opportunity to investigate the device in question within the 30 day reporting window, batch history records for the build demonstrate conformance with all safety and performance specifications, which would suggest the device and labeling would unlikely be the failure, rather use error.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LUMARX
Type of Device
LIGHT BASED HAIR REMOVAL DEVICE
Manufacturer (Section D)
SHASER, INC
lexington MA
Manufacturer Contact
carl kammer
10 maguire road
building one
lexington, MA 02421
MDR Report Key4698852
MDR Text Key20366369
Report Number3009088196-2015-00001
Device Sequence Number1
Product Code ONF
Combination Product (y/n)N
PMA/PMN Number
120080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Remedial Action Patient Monitoring
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2015
Device Operator Other
Date Manufacturer Received03/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2014
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
-
-