FDA.reportPublic FDA data

CLEAR+BRILLIANT

Primary DI
00816995027317
Brand
CLEAR+BRILLIANT
Company
SOLTA MEDICAL
Model
CBT-HP-1440
Catalog number
CBT-HP-1440
Device description
CLEAR+BRILLIANT 1440 HANDPIECE
Published
2020-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816995027317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816995027317008169950273178169950273170816995027317

GMDN Terms#

Term, Definition table
TermDefinition
Laser skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated laser-based energies (e.g., Er:YAG lasers; Er:Glass lasers, long-pulsed Nd:YAG laser, and Q-switched Nd:YAG laser) used for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This device is connected to a generator and is applied by a practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079999584
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816995027775Fraxel FTXMC15MM12MC15MM122025-04-02
00816995027782Fraxel FTXMC7MM12MC7MM122025-04-02
00816995027799Fraxel FTXMCSYSFTX-RMCSYSFTX-R2025-04-02
00816995027805Fraxel FTXMCSYSFTXMCSYSFTX2025-04-02
00816995021513VASERP010338-03P010338-032022-04-08
00816995022633ORIGINS810-MCBT5033PXNR810-MCBT5033PXNR2022-04-08
00816995022664ORIGINS810-MCBU3020LLNR810-MCBU3020LLNR2022-04-08
00816995022718ORIGINS810-MCBU3030VXNR810-MCBU3030VXNR2022-04-08
00816995022787ORIGINS810-MCBU4030PXNR810-MCBU4030PXNR2022-04-08
00816995022800ORIGINS810-MCBU4030VXNR810-MCBU4030VXNR2022-04-08
00816995022879ORIGINS810-MCBU5030PXNR810-MCBU5030PXNR2022-04-08
00816995022893ORIGINS810-MCBU5030VXNR810-MCBU5030VXNR2022-04-08
00816995022916ORIGINS810-MDMD3030PXNR810-MDMD3030PXNR2022-04-08
00816995022947ORIGINS810-MDMD4030PXNR810-MDMD4030PXNR2022-04-08
00816995022978ORIGINS810-MDMD5030PXNR810-MDMD5030PXNR2022-04-08
00816995023005ORIGINS810-MDMD6030PXNR810-MDMD6030PXNR2022-04-08
00816995023050ORIGINS810-SGBU4030PXNR810-SGBU4030PXNR2022-04-08
00816995023173ORIGINS810-SLBU4026PXNR810-SLBU4026PXNR2022-04-08
00816995023418ORIGINS810-SPSP4033VXNR810-SPSP4033VXNR2022-04-08
00816995023500ORIGINS810-STBT3026BDCX810-STBT3026BDCX2022-04-08

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