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Olo

El.En S.P.A.

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

El.En S.P.A.
Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251432
Device name
Olo
Company
El.En S.P.A.
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-05-08
Decision date
2025-08-06
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Vascular treatmentPigment treatment
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

Olo is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.

Intended Use

Olo is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.

Device Description

Olo is a device which emits laser radiation with a wavelength of 532 nm, which is delivered to the tissue through a transfer fiber and a handpiece or a scanner. The Olo device electrical specifications are: 100-240V~, 50/60Hz, 600VA.

Summary parsed at:2026-06-01 05:23:14 UTC

Predicate devices

1

K251432 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K251432 as a predicate