FDA.reportPublic FDA data

MultiPulse HoPLUS

Primary DI
04058784000996
Brand
MultiPulse HoPLUS
Company
Asclepion Laser Technologies GmbH
Model
J19-1151-000
Catalog number
J19-1151-000
Device description
Holmium Laser for Surgery
Published
2019-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161257000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161257000MultiPulse HoPLUSAsclepion Laser Technologies GmbH2017-03-31GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058784000996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058784000996040587840009964058784000996

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4936417700401service@asclepion.com

Regulatory Flags#

DUNS number
332247852
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058784002655MultiPulse TFLJ19-8000-000J19-8000-0002025-11-27
04058784002693MultiPulse TFLJ19-8100-000J19-8100-0002025-11-27
04058784001542OMNIO10-0200-0002025-08-08
04058784000132TattooStar16412018-06-04
04058784000026QuardoStar PRO14902016-09-17
04058784000033QuadroStar PRO14912016-09-17
04058784000057QuardoStar PRO14932016-09-17
04058784002037MultiCut Blade 350839-3200-0002024-11-22
04058784002044MultiCut Blade 400839-3300-0002024-11-22
04058784002617DermablateM18-4200-0002024-11-11
04058784002624DermablateM18-4300-0002024-11-11
04058784000279MeDioStarM10-0200-0002020-03-27
04058784001986MultiPulse HoPLUSJ19-1191-000J19-1191-0002024-06-25
04058784001009MultiPulse HoPLUSJ19-1161-000J19-1161-0002019-12-02
04058784000224MCL 31 Dermablate18232018-01-30
04058784000071MeDioStar NeXT PRO15922016-11-14
04058784000095SmoothPulse PRO159222016-09-17
04058784000101Pronto159212016-09-17
04058784000293Bare Fiber 2.1 20029542019-03-01
04058784000309Bare Fiber B 2.1 27229232019-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423605MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423650MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423667MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776424510MillenniumAvalign Technologies, Inc.GCJ2026-08-07
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
06973011720103Q Switched Nd: YAG Laser machineSanhe LEFIS Electronics Co., LtdGEX2026-08-07
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31