FDA UDI
In Commercial Distribution
🇺🇸 United States
AROMA GRAND
DI: 08800017500126
·
Model: 1.0
·
Daeju Medi Tech Engineering
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AROMA GRAND
- Primary DI
- 08800017500126
- Version / Model
- 1.0
- Company Name
- Daeju Medi Tech Engineering
- Labeler DUNS
- 694492044
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-11
- Public Version
- 3
- Public Version Date
- 2024-02-14
- Public Version Status
- Update
- Public Device Record Key
- a540a6e0-91ca-440a-ba0b-cdf47de0f490
Device Description
The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece.
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | 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 | 08800017500126 | GS1 |
Customer Contacts
- Phone
- +82222080905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211637 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 55 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity