FDA.reportPublic FDA data

OLO

Primary DI
08034108513218
Brand
OLO
Company
DEKA M.E.L.A. SRL
Model
M141A1
Catalog number
M141A1
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.
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251432000OloEl.En S.P.A.2025-08-06GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034108513218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034108513218080341085132188034108513218

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal1060 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
629381096
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034108513270ONDA PROM116V1M116V12025-11-17
08034108512877TOROM136E1M136E12026-03-11
08034108513317DEKA LUXEA PLUSM117B1117B12025-12-16
08034108512679Plus HandpieceE098H12025-10-22
08034108513263body ESTIQM116H1M116H12025-09-26
08034108512426ERISE Laser HandpieceE262B12023-06-16
08057017760689DEKA PHYSIQ 360M134A1M134A12023-10-11
08034108512419BioStimul HandpieceN378C12023-06-16
08034108512464PRISMAM135A12024-09-17
08034108512891MOTUS PROM130N12025-02-04
08034108512907MOTUS PRO AXM130P12025-02-04
08034108512495DEKA LILYM135B12024-09-17
08034108512730PRISMA EMS MODULEF552012024-09-17
08034108512709DEKA SMARTXIDE PROM079BI1M079R12024-04-09
08034108512808SMARTXIDE TETRA PROM118G12024-04-08
08034108512846Scar 3 PROF540A12024-04-04
08034108512655Elite iQ PROM122K1M122K12024-03-13
08034108512525AGAIN PROM126AA12023-10-31
08034108512532SYMPHONYM126AB12023-10-31
08057017760771DEKA PHYSIQ 360 EMS ModuleF53701F537012023-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07