FDA UDI
In Commercial Distribution
🇺🇸 United States
HELIOS 785 Pico Body
DI: 08800035501860
·
Model: HELIOS 785 Pico (1754V2) Body
·
Laseroptek Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HELIOS 785 Pico Body
- Primary DI
- 08800035501860
- Version / Model
- HELIOS 785 Pico (1754V2) Body
- Company Name
- Laseroptek Co.,Ltd
- Labeler DUNS
- 689856875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-18
- Public Version
- 2
- Public Version Date
- 2025-04-04
- Public Version Status
- Update
- Public Device Record Key
- 08bec02b-9370-4449-b921-7eeaf4beabc8
Device Description
HELIOS 785 Pico (1754V2) Body
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 |
|---|---|---|---|---|
| 36150 | General/multiple surgical frequency-doubled solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08800035501983 | GS1 | Carton Box | 1 | Not in Commercial Distribution | 2025-02-18 |
| Primary | 08800035501860 | GS1 | ||||
| Package | 08800035501990 | GS1 | Wooden Box | 1 | Not in Commercial Distribution | 2025-02-18 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243780 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 40 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 85 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- -25 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 93 Degrees Celsius