FDA.reportPublic FDA data

Icoone Laser

Primary DI
18057592610307
Brand
Icoone Laser
Company
I-TECH INDUSTRIES SRL
Model
Icoone Laser (also referred to as Icoone beauty la
Catalog number
610BC04
Device description
Icoone Laser (also referred to as Icoone Beauty Laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body.The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 610BEC04) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (10mW)The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
Published
2023-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric
NUVMassager, Vacuum, Light Induced Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211272000ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl2021-06-22NUV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18057592610307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805759261030718057592610307

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure20KiloPascal

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure30 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9149071850stan@skinsciencesolutions.com

Regulatory Flags#

DUNS number
440986833
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057592610676Icooneicoone-M695WC342026-02-19
18057592610246icoone Laser HealthcareICOONE h (also referred to as ICOONE LASER and ICO601EC142023-11-30
18057592610253icoone HealthcareICOONE; ICOONE BEAUTY; ICOONE H601HC142023-11-30
18057592610260Icoone MedicalICOONE; ICOONE BEAUTY; ICOONE H660HC142023-11-30
18057592610277Icoone Laser MedICOONE Laser Med (also called ICOONE MEDICAL LASER650EC242023-11-30
18057592610321IcooneICOONE; ICOONE BEAUTY; ICOONE H620WC342023-11-30
18057592610369Icoone Laser BodyIcoone laser body (also referred to as Icoone body611BC142023-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06927753902426MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902433MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902440MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902457MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902464MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902471MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902488MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902495MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902501MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902518MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902525MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902532MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902549MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902556MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902563MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902594MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902600MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753906059MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
16927753900009MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
00810140063236RENPHO Foot MassagerJoicom CorporationISA2026-10-27
00810140063243RENPHO Foot MassagerJoicom CorporationISA2026-10-27
06974958310631mitoredlightShenzhen Idea Light LimitedISA2026-10-22
00810140063229Renpho RejuvenJoicom CorporationISA2026-10-20
00810226442610ViveVIVE HEALTH LLCISA2026-10-09
00810226442627ViveVIVE HEALTH LLCISA2026-10-09
00810226442634ViveVIVE HEALTH LLCISA2026-10-09
00810226442641ViveVIVE HEALTH LLCISA2026-10-09
00850018480888Primo PassiPrimo Passi LLCISA2026-09-21
00860014139918QUASONIQ+Global Good, Corp.ISA2026-09-21
06977444420005Shuhai JingweiShuhai Jingwei (Shenzhen) Information Technology Co., Ltd.ISA2026-09-04