FDA.reportPublic FDA data

Apollo

Primary DI
00852753008969
Brand
Apollo
Company
PIVOTAL HEALTH SOLUTIONS, INC.
Model
Handheld, HH
Device description
Apollo laser handheld
Published
2018-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852753008969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852753008969008527530089698527530089690852753008969

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

Regulatory Flags#

DUNS number
826316098
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008449871Tradeflex Flexion TableE90182021-08-27
00850008449888Tradeflex Flexion TableE9018-L2021-08-27
00850008449918Tradeflex Flexion TableE92182021-08-27
00850008449925Tradeflex Flexion TableE9218-L2021-08-27
00854798000793Torque TableTT10002026-05-27
00854798000526Elevating Hand Therapy TableHT1002026-03-27
00854798000533Elevating Hand Therapy TableHT2002026-03-27
00854798000571Elevating Hand Therapy TableHT9002026-03-27
00854798000588Elevating Hand Therapy TableHT17002026-03-27
00854798000601Elevating Hand Therapy TableHT19002026-03-27
00854798000656Elevating Hand Therapy TableREV1002026-03-27
00854798000663Elevating Hand Therapy TableREV2002026-03-27
00854798000670Elevating Hand Therapy TableREV9002026-03-27
00854798000748Elevating Hand Therapy TableREV17002026-03-27
00854798000762Elevating Hand Therapy TableREV19002026-03-27
00854798000786Portable Parallel BarsPTPB-10002026-03-27
00854798000465Parallel Bars Electric Platform MountEPB10080-NE2026-01-22
00854798000472Parallel Bars Electric Platform MountEPB10080B-NE2026-01-22
00854798000489Parallel Bars Electric Platform MountEPB10010-NE2026-01-22
00854798000496Parallel Bars Electric Platform MountEPB10010B-NE2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCILY2026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310600mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310617mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
B5171301410Energy Flo TDP Heat LampAcu MarketILY2026-08-21
00850087184007HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688989HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688996HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00841436126366LED Instrument CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ILY2026-07-27
00810140062833RENPHOJoicom CorporationILY2026-07-24
00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27