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UltraClear Fractional Laser System

Fa International, LP

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

Product code GEX· 21 CFR 878.4810

Summary PDF

Company

Fa International, LP
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K210847
Device name
UltraClear Fractional Laser System
Company
Fa International, LP
Country / Region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-03-22
Decision date
2021-12-10
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Skin resurfacingVascular treatmentAcne treatment
Primary application
Skin resurfacing
Classification source
AI classified

Indications for Use

The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use:
- General skin resurfacing procedures
- Ultra mode is further indicated for the following fractional applications:
  - Treatment of wrinkles
  - Epidermal nevi
  - Telangiectasia
  - Spider veins
  - Actinic chelitis
  - Keloids
  - Verrucae
  - Skin tags
  - Anal tags
  - Keratoses
  - Scar revision (including acne scars).

Intended Use

The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use: General skin resurfacing procedures. Ultra mode is further indicated for the following fractional applications: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

Device Description

The UltraClear Laser System is substantially equivalent in design, function, operating principles, and intended use to the Joule ProFractional System (K180508).

Summary parsed at:2026-06-01 05:42:50 UTC

Predicate devices

2

K210847 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K210847 as a predicate