Manufacturer
ORO Co., Ltd.CAPRI
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K254271
- Device name
- CAPRI
- Company
- ORO Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-12-30
- Decision date
- 2026-02-26
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cuttingAcne treatmentSkin resurfacingOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
CAPRI is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, Treatment of Sebaceous Hyperplasia.
Intended Use
CAPRI is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, Treatment of Sebaceous Hyperplasia.
Device Description
CAPRI is a diode laser which delivers energy at a wavelength of 1450 nm. Laser energy is delivered through an optical fiber that is attached to the handpiece. Laser guide tip is attached to the handpiece ensures that the spot is focused on the skin and serves as the laser beam aiming device. CAPRI consists of the following components: Main Unit, Accessories: Handpiece & Laser Guide Tip, Foot Switch, Remote Interlock Connector, Gas Spray (HFC-134), Key Switch, Eye Protection Goggle.
Summary parsed at:2026-06-01 05:19:05 UTC
Predicate devices
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Cited as predicate
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