FDA.reportPublic FDA data

DEKA PHYSIQ 360

Primary DI
08057017760689
Brand
DEKA PHYSIQ 360
Company
DEKA M.E.L.A. SRL
Model
M134A1
Catalog number
M134A1
Device description
The PHYSIQ 360 is a diode laser device. The device is provided with 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
Published
2023-10-11
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
PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKTLaser For Disruption Of Adipocyte Cells For Aesthetic UseGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231971000DEKA PHYSIQ 360El.En S.P.A.2023-09-26PKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057017760689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057017760689080570177606898057017760689

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal1060 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
629381096
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034108513270ONDA PROM116V1M116V12025-11-17
08034108512877TOROM136E1M136E12026-03-11
08034108513317DEKA LUXEA PLUSM117B1117B12025-12-16
08034108512679Plus HandpieceE098H12025-10-22
08034108513263body ESTIQM116H1M116H12025-09-26
08034108513218OLOM141A1M141A12025-08-27
08034108512426ERISE Laser HandpieceE262B12023-06-16
08034108512419BioStimul HandpieceN378C12023-06-16
08034108512464PRISMAM135A12024-09-17
08034108512891MOTUS PROM130N12025-02-04
08034108512907MOTUS PRO AXM130P12025-02-04
08034108512495DEKA LILYM135B12024-09-17
08034108512730PRISMA EMS MODULEF552012024-09-17
08034108512709DEKA SMARTXIDE PROM079BI1M079R12024-04-09
08034108512808SMARTXIDE TETRA PROM118G12024-04-08
08034108512846Scar 3 PROF540A12024-04-04
08034108512655Elite iQ PROM122K1M122K12024-03-13
08034108512525AGAIN PROM126AA12023-10-31
08034108512532SYMPHONYM126AB12023-10-31
08057017760771DEKA PHYSIQ 360 EMS ModuleF53701F537012023-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060830444Venus BlissVenus Concept Inc.PKT2023-06-08
00810060830987Venus Bliss MaxVenus Concept Inc.PKT2023-06-08
07290016541281BLISS SYSTEMVENUS CONCEPT LTDPKT2021-07-14
07290016541632BLISS SYSTEMVENUS CONCEPT LTDPKT2021-07-14
07290016541564BODY LASER APPLICATOR SERVICE PACK, BlissVENUS CONCEPT LTDPKT2021-07-14
07290016541618(MP)2 APPLICATOR BLISSVENUS CONCEPT LTDPKT2021-07-14
07290016541625BODY LASER APPLICATOR BLISSVENUS CONCEPT LTDPKT2021-07-14
07290016541717(MP)2 APPLICATOR SERVICE PACK, BlissVENUS CONCEPT LTDPKT2021-07-14
07290016541724Belt BlissVENUS CONCEPT LTDPKT2021-07-14
06970745918516ApolomedShanghai Apolo Medical Technology Co.,LtdPKT2021-03-26
00841494107925ASSY, MASK, Petite, Submental AdapterCynosure, LLCPKT2019-09-18
00841494107994RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLYCynosure, LLCPKT2018-01-18
00841494107956ASSY, FINAL LASER, SCULPSURE, SUB ONLYCynosure, LLCPKT2017-11-29
00841494107963ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZILCynosure, LLCPKT2017-11-29
00841494107468ASSY, MASK FLEX CIRCUIT, MED, SUBCynosure, LLCPKT2017-09-26
00841494100032SculpSure laser assemblyCynosure, LLCPKT2017-07-26
00841494100049SculpSure ApplicatorCynosure, LLCPKT2017-07-26
00841494106867SculpSure Applicator, RefurbishedCynosure, LLCPKT2017-07-24
00841494106775SculpSure, Laser Assembly, BrazilCynosure, LLCPKT2017-07-24