FDA UDI
In Commercial Distribution
🇺🇸 United States
Apolomed
DI: 06970745912309
·
Model: HS-230
·
Shanghai Apolo Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Apolomed
- Primary DI
- 06970745912309
- Version / Model
- HS-230
- Company Name
- Shanghai Apolo Medical Technology Co., Ltd.
- Labeler DUNS
- 529854247
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- 1d516fc5-eca2-4575-8f63-1fa1f2fef299
- Distribution End Date
- 2027-11-29
Device Description
Fiber Laser Treatment System
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57890 | Dermatological dye laser system | A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite organic compounds (i.e., dye) used as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation to incise, excise, ablate, and vaporize soft tissues for dermatological applications such vascular/skin lesion, acne and wrinkle removal or reduction. It typically includes a light source, flexible fibreoptic delivery/positioning device(s), and controls/foot-switch for pulsed mode operation. During emission the dye has to be optically excited by another light source (e.g., another laser or flash lamp). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970745912309 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221770 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius