Remington Products
- Primary DI
- 10074590512172
- Company
- SPECTRUM BRANDS, INC.
- Model
- IPL6000USA
- Device description
- Intense Pulsed Light OTC hair removal device
- Published
- 2016-09-30
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Regulatory Flags
- DUNS number
- 001951946
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10074590512172 | Package | GS1 | 2 | In Commercial Distribution |
| 00074590512175 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 10074590512172 | Package | GS1 | 2 | box | 00074590512175 | | In Commercial Distribution |
| 00074590512175 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | General, Plastic Surgery | 878.4810 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K120080 | 000 | SHASER HRS2 HAIR REMOVAL SYSTEM | Shaser, Inc. | 2012-05-25 | ONF |
GMDN Terms
| Term | Definition |
|---|
| Intense pulsed light skin surface treatment system | A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 560 - 1200nm [intense pulsed light (IPL)] to cause heat ablation of pigmented skin cells (selective photothermolysis) to treat a variety of skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| 1-800-736-4648 | xx@xx.xxx |
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