FDA.reportPublic FDA data

GIGAA

Primary DI
16977331780035
Brand
GIGAA
Company
Gigaalaser Company Ltd.
Model
VELASII-30B
Device description
Physical therapy+Clear nail
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242755000Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.2025-05-19ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16977331780035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697733178003516977331780035

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableAn electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618495205
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16977331780080GigaaMedGBOX-15D2026-03-19
16977331780059GIGAACHEESEII-10B2025-08-15
16977331780011GIGAAGBOX-20B2025-08-13
16977331780028GIGAAVELASII-30A2025-08-13
16977331780042GIGAAGBOX-15AB 2025-08-13
06977331780007GIGAAGBOX-15A2024-11-30
06977331780014GIGAAGBOX-15B2024-11-01
06977331780021GIGAAGBOX-20B2024-11-01
06977331780038GIGAAGBOX-15AB2024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09361725008346BON CHARGELight Tree Ventures Europe B.V.ILY2026-05-25
09361725008360BON CHARGELight Tree Ventures Europe B.V.ILY2026-05-25
06976812430219TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06976812430226TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06976812430233TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06977863220149Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220156Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220163Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220170Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06979292890009SummusLasxbot (Shenzhen) Robot Co., LtdILY2026-02-27
08500723550001SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550018SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550025SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550049SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550056SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550063SunPowerLEDKERBER USA INC.ILY2026-02-26
00840397513284Sharper ImageMerchsource, LLCILY2026-02-17
06977782490005Quasar MDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-02-11
06978181510325QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-10
06956822893013SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06956822893020SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06956822893037SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06978181510301QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-02
06978181510318QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-02
06979812520034MarrisJjwXiamen Langxing Medical Technology Co., Ltd.ILY2026-01-26
06979322350015N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350022N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350039N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350046N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350053N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22