FDA UDI
In Commercial Distribution
🇺🇸 United States
Sebacia Microparticles
DI: G256SEB2503PUS1
·
Model: SEB-250-3P-US
·
Coronado Aesthetics, LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
9
Basic Information
- Brand Name
- Sebacia Microparticles
- Primary DI
- G256SEB2503PUS1
- Version / Model
- SEB-250-3P-US
- Catalog Number
- SEB2503PUS
- Company Name
- Coronado Aesthetics, LLC
- Labeler DUNS
- 118668178
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2022-10-04
- Public Version
- 1
- Public Version Date
- 2022-10-12
- Public Version Status
- New
- Public Device Record Key
- 63936dfc-15f1-4eb1-8879-81b9e4b9ac0c
Device Description
Sebacia Microparticles Box of 9 vials
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| QCY | Laser Absorbing Particles | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G256SEB2503PUS1 | HIBCC | ||||
| Unit of Use | G256SEB2503PUS0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181518 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Milliliter |