FDA UDI
In Commercial Distribution
🇺🇸 United States
AGNES ULTRA
DI: 08800067700453
·
Model: AGNES ULTRA
·
AGNES MEDICAL CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AGNES ULTRA
- Primary DI
- 08800067700453
- Version / Model
- AGNES ULTRA
- Company Name
- AGNES MEDICAL CO., LTD.
- Labeler DUNS
- 987426048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-16
- Public Version
- 2
- Public Version Date
- 2026-04-28
- Public Version Status
- Update
- Public Device Record Key
- 658c1a8a-ab44-430a-a0f1-433413f18a12
Device Description
AGNES Ultra is used to coagulate the patient's tissue. AGNES Ultra is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures.
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66285 | Intradermal radio-frequency ablation system | An assembly of devices designed to apply radio-frequency (RF) energy to heat the dermal layer of the skin (e.g., the sebaceous glands) [invasive] for ablation (e.g., thermolysis) during an aesthetic procedure (e.g., acne treatment). It primarily consists of an electrically-powered control unit intended to produce and regulate the RF energy, and a connected monopolar RF applicator (probe) to deliver the RF energy to the skin; it may in addition include a bipolar (noninvasive) RF applicator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800067700453 | GS1 |
Customer Contacts
- Phone
- +823180209717
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250217 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity