FDA UDI
In Commercial Distribution
🇺🇸 United States
MUSTBEATY
DI: 06978500910065
·
Model: M8022
·
Mustech Electronics Co., Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MUSTBEATY
- Primary DI
- 06978500910065
- Version / Model
- M8022
- Company Name
- Mustech Electronics Co., Limited
- Labeler DUNS
- 421369118
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-14
- Public Version
- 1
- Public Version Date
- 2025-04-22
- Public Version Status
- New
- Public Device Record Key
- 85d2cd40-c462-4955-9043-42e2853135bb
Device Description
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65776 | Home-use intense pulsed light hair removal unit | A hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16978500910062 | GS1 | Transport package | 12 | In Commercial Distribution | |
| Primary | 06978500910065 | GS1 |
Customer Contacts
- Phone
- +86-18926540294
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250131 | 000 |