FDA UDI
In Commercial Distribution
🇺🇸 United States
C + B Pelo
DI: B12510420
·
Model: 1042
·
GME German Medical Engineering GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- C + B Pelo
- Primary DI
- B12510420
- Version / Model
- 1042
- Catalog Number
- 1042
- Company Name
- GME German Medical Engineering GmbH
- Labeler DUNS
- 342234451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-16
- Public Version
- 3
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- ec2ebafd-ba2b-4a92-932c-10c36e47ab5a
Device Description
Scanned diode laser 808 nm for hair reduction
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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58786 | Dermatological diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B12510420 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141063 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 99 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 89 Percent (%) Relative Humidity