FDA.reportPublic FDA data

PRISMA

Primary DI
08034108512464
Brand
PRISMA
Company
DEKA M.E.L.A. SRL
Model
M135A1
Device description
The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece.The overall weight is approximately 62 kg and the sizes 47 x 56 x 106 cm (LxWxH) without external partsand reclined display and 47 x 56 x 202 cm (LxWxH) with handpiece holders at maximum extensionElectrical requirements: 115V~, 50/60Hz, 2300VA.The operator interacts directly with the external portions of the system displayed in the following.
Published
2024-09-17
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
GEIElectrosurgical, Cutting & Coagulation & Accessories
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233473000
K250281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233473000DEKA LOTUSEl.En S.P.A.2024-05-16ONF
K250281000DEKA LOTUSEl.En S.P.A.2025-02-26ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034108512464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034108512464080341085124648034108512464

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.

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
08057017760689DEKA PHYSIQ 360M134A1M134A12023-10-11
08034108512419BioStimul HandpieceN378C12023-06-16
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

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Primary DI, Brand, Company table
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