FDA.reportPublic FDA data

OvationULT

Primary DI
00860009854598
Brand
OvationULT
Company
Body Balance System, LLC
Model
SST (SGS)
Device description
OvationULT private labelled for SST with SGS certification.
Published
2025-10-30
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009854598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009854598008600098545988600098545980860009854598

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2703173980frank.davis@globrands.com
4237040290evan.evans@suntancity.com
5196024212laurie@uvalux.com
3183479897jeff.lauseng@suntancity.com
3199818260brandon.hoffman@suntancity.com
4176933050austin.hobbs@suntancity.com
4025259306cory.frasier@suntancity.com

Regulatory Flags#

DUNS number
876724449
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009854574PremierRLTPremierRLT2025-03-04
00860009854536OvationULTSST2024-06-21
00860009854529OvationULT2023-09-18
00860009854550ApolloGLOW2025-03-04
00860009854543ApolloARC2025-03-04
00860009854567OvationLITE2025-03-04
00860009854581Foot VitalizerFoot Vitalizer2025-03-04

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Primary DI, Brand, Company table
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G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
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B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
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B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
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G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
08906172600081Theraray LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
00810071230509RegenalaseIPG Medical CorporationILY2025-06-09
00810071230516RegenalaseIPG Medical CorporationILY2025-06-09
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16978368600013 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600020 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600037 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05