FDA.report

510(k) K133201

Device
SHASER V-MINI 2 HAIR REMOVAL SYSTEM
Applicant
SHASER, INC.
510(k) number
K133201
Product code
ONF  
Decision
Substantially Equivalent (SESE)
Decision date
2014-02-12
Date received
2013-10-17
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
ANTHONY BURNS
Address
10 Maguire Rd. Bldg. One Lexington MA US 02421 02421

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
10074590546030RemingtonSPECTRUM BRANDS, INC.2019-09-26
10074590535478RemingtonSPECTRUM BRANDS, INC.2019-09-26
10074590542926RemingtonSPECTRUM BRANDS, INC.2019-09-25

Legacy Summary

summary

FDA Review

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