Manufacturer
El.En S.P.A.Olo
Country / Region:Italy (IT)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
- 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
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Not ingested
K251432 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251432 as a predicate