FDA.reportPublic FDA data

ML 830®

Primary DI
00859626006053
Brand
ML 830®
Company
MICROLIGHT CORPORATION OF AMERICA
Model
ML-830-01-007
Catalog number
ML-830-01-007
Device description
Safety Glasses
Published
2016-08-15
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
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
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain TherapyPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859626006053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859626006053008596260060538596260060530859626006053

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding gogglesA personal protective device intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical and dental procedures. It will typically be designed as goggles consisting of a single unit with lenses, side shields, top shields, and bottom shields made from clear lead-equivalent materials, e.g., glass or plastic. The lenses and shields offer additional physical barrier protection from liquid radioactive materials. Goggle lenses may be either uncorrected (non-prescription) or corrected (prescription) for the individual's vision.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
281-433-4648XX@XX.XX

Regulatory Flags#

DUNS number
137829417
Device count
1
Premarket exempt
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
00859626006343ML 830®ML-830-07-100ML-830-07-1002019-04-12
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898616351141Therapy US (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-12-17
06957510600852LASPOTWuhan Guangdun Technology Co.,Ltd.NHN2025-09-23
16957510600019LASPOTWuhan Guangdun Technology Co.,Ltd.NHN2025-09-23
07898616351127Therapy EC (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-01-21
07898616351134Therapy XT (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-01-21
00627987397499TheralaseTheralase IncNHN2023-12-14
00627987397475TheralaseTheralase IncNHN2023-10-27
00850056256407Collagentex Series Tanses Technologies IncNHN2023-10-16
00850056256445Collagentex Series Tanses Technologies IncNHN2023-10-16
00852556007008FibroLuxMulti Radiance MedicalNHN2022-11-08
00858985006278Erchonia GVLERCHONIA CORPORATION, LLCNHN2022-10-31
00858985006193FX405ERCHONIA CORPORATION, LLCNHN2020-08-10
00858985006186FX635ERCHONIA CORPORATION, LLCNHN2020-06-19
00859626006343ML 830®MICROLIGHT CORPORATION OF AMERICANHN2019-04-12
B271LDI200P0LD-I 200+Meditech International IncNHN2018-02-01
00869340000305LaserTouchOneLaser Health Technologies, LLCNHN2017-05-11
00858985006001Base StationERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006025EVLERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006032EVRLERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006049FX635ERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006063PL TouchERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006087VLSERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006094XLR8ERCHONIA CORPORATION, LLCNHN2016-09-24
B420LD1000LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100A0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100B0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100C0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100D0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000PTS0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
00859626006008ML 830®MICROLIGHT CORPORATION OF AMERICANHN2016-08-15