FDA UDI
In Commercial Distribution
🇺🇸 United States
Forma Light
DI: 07290016681017
·
Model: FS60000
·
FORMATK SYSTEMS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Forma Light
- Primary DI
- 07290016681017
- Version / Model
- FS60000
- Catalog Number
- FS60000
- Company Name
- FORMATK SYSTEMS LTD
- Labeler DUNS
- 532396673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-18
- Public Version
- 4
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- 70197ce5-c5b7-4132-8542-c9c8d16e1e2b
Device Description
System supporting IPL (Intense Pulsed Light) applicators for various treatments such as Hair Removal, Acne, Pigmented 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
- Yes
- 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 |
|---|---|---|---|---|
| 47705 | Cosmetic red-light phototherapy system, professional | An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in a professional setting. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by healthcare personnel typically for patient body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016681017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160195 | 000 |