FDA.reportPublic FDA data

MD Elite LaserPro

Primary DI
00860007876813
Brand
MD Elite LaserPro
Company
MDElite Laser and Aesthetic, LLC
Model
LaserPro
Device description
MD Elite LaserPro - Diode Laser System - FDA 510(k) K212478
Published
2022-01-28
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212478000Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.2022-01-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007876813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007876813008600078768138600078768130860007876813

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118440103
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007876820iLightProiLightPro2022-07-09
00860007876837iProEliteiProElite2022-07-09
00860007876806MDElite iProXiProX2022-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817495025216Refurbished Vbeam PerfectaCandela CorporationGEX2026-11-04
00817495025223Refurbished Vbeam PerfectaCandela CorporationGEX2026-11-04
06973511890214SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-10-30
06973011720134Diode Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-10-16
00840456400814MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456400821MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401293MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401309MOSES RaydarLUMENIS LTD.GEX2026-10-13
B17731226455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-10-08
B17700100852TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06970745912927ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912934ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912996ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
04053002150316Bare Fiber 400 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150415Bare Fiber 600 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150514CORONA 360 Fused 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
04053002150613CORONA Infinite Ring XSCF 600 1.6 USLight Guide Optics International SIAGEX2026-08-14
04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
06973011720103Q Switched Nd: YAG Laser machineSanhe LEFIS Electronics Co., LtdGEX2026-08-07
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29