Manufacturer
Accure Acne, Inc.Accure Laser System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
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
- K242035
- Device name
- Accure Laser System
- Company
- Accure Acne, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-07-12
- Decision date
- 2024-10-11
- 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 long-term treatment of mild to severe inflammatory acne vulgaris.
Intended Use
The Accure Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
Summary parsed at:2026-06-01 05:29:00 UTC
Predicate devices
0No predicate K numbers were extracted
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Cited as predicate
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