Sebacia Microparticles

Primary DI
20850002391019
Brand
Sebacia Microparticles
Company
SEBACIA, INC.
Model
SEB-250-3P-US
Catalog number
SEB-250-3P-US
Device description
Sebacia Microparticles ia a medical device consisting of engineered gold microparticles suspension intended for single use topical application. Sebacia Microparticles are designed to work as an accessory to a commercially available medically approved 1064nm laser by preferentially absorbing the light and converting it to heat, creating a focal thermal effect to the follicle and sebaceous gland for the treatment of acne vulgaris.
Published
2020-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QCYLaser Absorbing Particles

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
20850002391019PrimaryGS10
10850002391111Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085000239101920850002391019
1085000239111110850002391111

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

Contacts#

Phone, Email table
PhoneEmail
6788121138richard@sebacia.com

Regulatory Flags#

DUNS number
963219600
Device count
9
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G256SEB2503PUS1Sebacia MicroparticlesCoronado Aesthetics, LLCQCY2022-10-04