FDA.report

510(k) K140631

Device
LUMENA FH HAIR REMOVAL SYSTEM
Applicant
SHASER, INC.
510(k) number
K140631
Product code
ONF  
Decision
Substantially Equivalent (SESE)
Decision date
2014-05-16
Date received
2014-03-12
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
Special
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. Suite 120 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

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10074590543879Luma RxSPECTRUM BRANDS, INC.2016-09-30
10074590543862Luma RxSPECTRUM BRANDS, INC.2016-09-30
10074590543138Luma RxSPECTRUM BRANDS, INC.2016-09-30
10074590542377Luma RxSPECTRUM BRANDS, INC.2016-09-30
10074590540342Luma RxSPECTRUM BRANDS, INC.2016-09-30

Legacy Summary

summary

FDA Review

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