FDA.reportPublic FDA data

ML 830®

Primary DI
00859626006343
Brand
ML 830®
Company
MICROLIGHT CORPORATION OF AMERICA
Model
ML-830-07-100
Catalog number
ML-830-07-100
Device description
Smart Laser DP
Published
2019-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating
NHNPowered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain TherapyPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010175000
K080786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010175000MICROLIGHT 830 LASER SYSTEMMicrolight Corporation of America2002-02-06NHN
K080786000ML830TPMicrolight Corporation of America2008-10-03ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859626006343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859626006343008596260063438596260063430859626006343

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, home-useAn electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a healthcare provider in both a clinical setting and in the home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7135200668customerservice@microlightcorp.com

Regulatory Flags#

DUNS number
137829417
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859626006022ML 830®ML-830-01-002ML-830-01-0022016-08-15
00859626006039ML 830®ML-830-01-003ML-830-01-0032016-08-15
00859626006008ML 830®ML-830-01-000ML-830-01-0002016-08-15
00859626006046ML 830®ML-830-01-004ML-830-01-0042016-08-15
00859626006107ML 830®ML-830-02-000ML-830-02-0002016-08-15
00859626006176ML 830®ML-830-02-010ML-830-02-0102016-08-15
00859626006183ML 830®ML-830-04-000ML-830-04-0002016-08-15
00859626006251ML 830®ML-830-07-000ML-830-07-0002016-08-15
00859626006268ML 830®ML-830-07-001ML-830-07-0012016-08-15
00859626006275ML 830®ML-830-07-002ML-830-07-0022016-08-15
00859626006336ML 830®ML-830-01-005ML-830-01-0052016-08-15
00859626006213ML 830®ML-830-04-009ML-830-04-0092016-08-15
00859626006121GlobTekML-830-02-004ML-830-02-0042016-08-15
00859626006015ML 830®ML-830-01-001ML-830-01-0012016-08-15
00859626006299ML 830®ML-830-07-004ML-830-07-0042016-08-15
00859626006053ML 830®ML-830-01-007ML-830-01-0072016-08-15
00859626006077ML 830®ML-830-01-009ML-830-01-0092016-08-15
00859626006091NAML-830-01-013ML-830-01-0132016-08-15
00859626006114ML 830®ML-830-02-003ML-830-02-0032016-08-15
00859626006138ML 830®ML-830-02-005ML-830-02-0052016-08-15

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Primary DI, Brand, Company table
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