FDA.reportPublic FDA data

ZYE ALX

Primary DI
07898961835211
Brand
ZYE ALX
Company
VYDENCE MEDICAL
Model
25704
Catalog number
25704
Device description
ZYE ALX
Published
2024-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2
PDZLasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190007000Vydence Laser FamilyVydence Medical Industria E Comercio Ltda2019-03-01GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898961835211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898961835211078989618352117898961835211

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius70 Degrees Celsius

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
07898961835099intenseIR18073180732024-05-27
07898961835204ZYE YAG25705257052024-05-27
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
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALPDZ2026-02-18
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALPDZ2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
07898961835013ETHEREA-MXVYDENCE MEDICALONF2024-05-27
07898961835013ETHEREA-MXVYDENCE MEDICALPDZ2024-05-27
07898961835037LongPulseVYDENCE MEDICALPDZ2024-05-27
07898961835204ZYE YAGVYDENCE MEDICALONF2024-05-27
07898961835204ZYE YAGVYDENCE MEDICALPDZ2024-05-27
078989618352425-15/ltVYDENCE MEDICALPDZ2024-05-27
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03