FDA.reportPublic FDA data

Sphinx Jr.

Primary DI
04250341910308
Brand
Sphinx Jr.
Company
LISA Laser Products GmbH
Model
103 201 111
Device description
he Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media and non aqueous medium. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece endoscopic surgical instrument or similar approved device
Published
2026-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K132975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132975000SPHINX JRAllmed Systems, Inc.2014-03-18GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250341910308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250341910308042503419103084250341910308

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

Regulatory Flags#

DUNS number
315026396
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250341904413Sphinx103 001 010103 001 0102026-01-23
04250341908596RevoLix and RevoLix Jr.105 105 3312026-01-23
04250341908695RevoLix DUO105 301 111105 301 1112026-01-23
04250341910285Sphinx Jr.101 203 311101 203 3112026-01-23
04250341910599 OmniGuide RFID Surgical Fibers101 503 xxx101 503 6482026-01-23
04250341911695RevoLix HTL105 401 0102024-04-04
04250341911572FlexGuard101 503 6312018-09-21
14250341911579FlexGuard101 503 6312018-09-21

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Primary DI, Brand, Company table
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07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
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08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
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