DEVICE: Sebacia Microparticles (20850002391019)
Device Identifier (DI) Information
Sebacia Microparticles
SEB-250-3P-US
In Commercial Distribution
SEB-250-3P-US
SEBACIA, INC.
SEB-250-3P-US
In Commercial Distribution
SEB-250-3P-US
SEBACIA, INC.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62071 | Photothermal therapy gel |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QCY | Laser Absorbing Particles |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K181518 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 3 Milliliter |
Device Record Status
2eb8bdc9-8f72-4ac7-9d34-430f7a1956aa
June 29, 2020
1
June 19, 2020
June 29, 2020
1
June 19, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10850002391111
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6788121138
richard@sebacia.com
richard@sebacia.com