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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHASER, INC. ILIGHT IPL6750

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SHASER, INC. ILIGHT IPL6750 Back to Search Results
Model Number IPL6750
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Event Date 04/24/2017
Event Type  Injury  
Event Description
A consumer from (b)(6) region reported a burn injury when using model# ipl6750 and returned the device to the shop.
 
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Brand NameILIGHT IPL6750
Type of DeviceIPL6750
Manufacturer (Section D)
SHASER, INC.
8123 forsythia street
suite 120
middleton WI 53562
Manufacturer (Section G)
SHASER, INC.
Manufacturer Contact
lavee yang
8123 forsythia st
suite 120
middleton, WI 53562
6082786362
MDR Report Key7887204
MDR Text Key120690120
Report Number3005855240-2018-00001
Device Sequence Number1
Product Code ONF
Combination Product (y/n)Y
Reporter Country CodeHR
PMA/PMN Number
K120080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/23/2017,07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIPL6750
Device Catalogue NumberIPL6750
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/23/2017
Distributor Facility Aware Date07/19/2017
Device Age6 MO
Event Location Home
Date Report to Manufacturer07/23/2017
Date Manufacturer Received07/19/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/18/2018 Patient Sequence Number: 1
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