510(k) K223647

Device
CLEAR+BRILLIANT TOUCH® Laser System
Applicant
Solta Medical, Inc.
510(k) number
K223647
Product code
GEX
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-29
Date received
2022-12-06
Regulation
878.4810
Classification name
Powered Laser Surgical Instrument
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Related Records

Applicant Contact

Contact
Aditi Chaubal
Address
11720 N. Creek Pkway N. Suite 100 Bothell WA US 98011 98011

FDA Registration Numbers

Source Documents

510(k) summary PDF

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