FDA.report

510(k) K120080

Device
SHASER HRS2 HAIR REMOVAL SYSTEM
Applicant
SHASER, INC.
510(k) number
K120080
Product code
ONF  
Decision
Substantially Equivalent (SESE)
Decision date
2012-05-25
Date received
2012-01-11
Regulation
878.4810
Classification name
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GLEN EMELOCK
Address
32 Harrison St. Melrose MA US 02176 02176

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

summary

FDA Review

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