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Accure Laser

Accure Acne, Inc.

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

Product code GEX· 21 CFR 878.4810

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Company

Accure Acne, Inc.
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
K222109
Device name
Accure Laser
Company
Accure Acne, Inc.
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-07-18
Decision date
2022-11-17
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Acne treatment
Primary application
Acne treatment
Classification source
AI classified

Indications for Use

The Accure Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris.

Intended Use

The Accure Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris.

Summary parsed at:2026-06-01 05:40:17 UTC

Predicate devices

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