FDA.reportPublic FDA data

intenseIR

Primary DI
07898961835099
Brand
intenseIR
Company
VYDENCE MEDICAL
Model
18073
Catalog number
18073
Device description
intenseIR
Published
2024-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171443000Etherea MXVydence Medical Industria E Comercio Ltda2018-04-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898961835099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898961835099078989618350997898961835099

GMDN Terms#

Term, Definition table
TermDefinition
Light-energy skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+551633065050sac@vydence.com

Regulatory Flags#

DUNS number
904013281
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898786930030ZYE-ULTRA FDA31303313032026-02-18
07898786930047ONE FDA31304313042026-02-18
07898961835426handPICO26378263782025-01-21
07898961835013ETHEREA-MX18057180572024-05-27
07898961835020IPL-Sq18077180772024-05-27
07898961835037LongPulse18085180852024-05-27
07898961835044ProDeep20746207462024-05-27
07898961835051GoSmooth18097180972024-05-27
07898961835068DualMode20744207442024-05-27
07898961835082SIBERIAN-FIT17613176132024-05-27
07898961835204ZYE YAG25705257052024-05-27
07898961835211ZYE ALX25704257042024-05-27
078989618352283-10/vl21799217992024-05-27
078989618352353-24/hr21806218062024-05-27
078989618352425-15/lt21803218032024-05-27
078989618352598-18/hr21805218052024-05-27
07898961835266handPICO27185271852024-05-27
07898961835075ACROMA-QS18098180982024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
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B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.ILY2026-05-02
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
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16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.ILY2026-01-16
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
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
00810071230530RegenalaseIPG Medical CorporationILY2025-06-09
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