FDA.reportPublic FDA data

Spectrum Laser/IPL

Primary DI
00860564000317
Brand
Spectrum Laser/IPL
Company
ROHRER AESTHETICS, LLC
Model
Spectrum
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ONEPowered Light Based Non-Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONEPowered Light Based Non-Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860564000317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860564000317008605640003178605640003170860564000317

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment system generatorA mains electricity (AC-powered) mobile (on wheels) device that combines technologies and may include an intense pulsed light (IPL) or IPL with radio-frequency (RF) generator, fluorescent light generator, pulsed ultraviolet B (UVB) light generator, Er:YAG lasers, Er:Glass lasers, long-pulsed Nd:YAG lasers, and Q-switched Nd:YAG lasers, as part of a multi-modality skin surface treatment system intended to be used 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). Dedicated applicators are used to apply the different energies to the skin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083701842
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860564000324Phoenix CO2Phoenix2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057622080004MTONE EVOM & T SRLONE2025-04-15
08057622080011MTONE EVOM & T SRLONE2025-04-15
08057622080028MT ONEM & T SRLONE2025-04-15
08057622080035MT ONEM & T SRLONE2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONE2025-04-15
10841305105192SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305105338SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305105567SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305106144SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305109916SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111087SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111483SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111490SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111506SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111513SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111520SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111698SynergeticsSYNERGETICS USA, INC.ONE2020-09-18