FDA UDI
In Commercial Distribution
🇺🇸 United States
S-590
DI: 07290016681376
·
Model: FS90013
·
FORMATK SYSTEMS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- S-590
- Primary DI
- 07290016681376
- Version / Model
- FS90013
- Catalog Number
- FS90013
- Company Name
- FORMATK SYSTEMS LTD
- Labeler DUNS
- 532396673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-16
- Public Version
- 1
- Public Version Date
- 2019-01-16
- Public Version Status
- New
- Public Device Record Key
- b3bb12f5-b1e8-4c0b-8874-45e9d27e7282
Device Description
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Reduction of unwanted hair, Pigmented lesions and Vascular lesions
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 |
|---|---|---|---|---|
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45222 | Light-energy skin surface treatment system applicator | A handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016681376 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183307 | 000 |