FDA UDI
In Commercial Distribution
🇺🇸 United States
SkinStylus
DI: 00196852554485
·
Model: MP1209SL1
·
Esthetic Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SkinStylus
- Primary DI
- 00196852554485
- Version / Model
- MP1209SL1
- Company Name
- Esthetic Medical Inc
- Labeler DUNS
- 105045262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-12
- Public Version
- 2
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 7b7049b2-e0f1-4f25-9199-5ddfed767d2d
Device Description
The SkinStylus SteriLock® MicroSystem is a powered microneedling device, intended to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QAI | Powered Microneedle Device | General, Plastic Surgery | 878.4430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61216 | Cosmetic micro-needling electronic handpiece, professional | A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00196852554485 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200044 | 000 |