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Fraxel® FTX Laser System

Solta Medical

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Solta Medical
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K242142
Device name
Fraxel® FTX Laser System
Company
Solta Medical
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-07-22
Decision date
2024-08-21
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Skin resurfacing
Primary application
Skin resurfacing
Classification source
AI classified

Intended Use

)
to legally marketed

Summary parsed at:2026-06-01 05:29:06 UTC

Predicate devices

0

No predicate K numbers were extracted

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Cited as predicate

0

No later 510(k)s cite this device yet

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