FDA.reportPublic FDA data

Sebacia Microparticles

Primary DI
G256SEB2503PUS1
Brand
Sebacia Microparticles
Company
Coronado Aesthetics, LLC
Model
SEB-250-3P-US
Catalog number
SEB2503PUS
Device description
Sebacia Microparticles Box of 9 vials
Published
2022-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
QCYLaser Absorbing Particles

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
QCYLaser Absorbing ParticlesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181518000Sebacia MicroparticlesSebacia, Inc.2018-09-06QCY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G256SEB2503PUS1PrimaryHIBCC0
G256SEB2503PUS0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Photothermal therapy gelA non-sterile, topically-applied gel/suspension intended to be used in conjunction with a lamp/laser to treat an inflammatory skin disorder (e.g., rosacea, psoriasis, acne) as part of photothermal therapy (PTT). It contains micro-/nano-particles intended to be delivered to a dermal structure (e.g., sebaceous glands, hair follicles), whereby absorption of light causes them to heat up (photothermal heating) to produce a therapeutic effect. It is intended to be used by a healthcare professional in a clinical setting. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118668178
Device count
9
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
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08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
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008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
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00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16