Identity
- Trade Name
- E1 Handpiece (L) FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Model / Reference
- EU0016-002RH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873121236 FDA UDI
- 510(k) Number
- K020080 FDA UDI
- FDA Product Code
- EKZ FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrosurgical system
E1 Handpiece (L) by Bonart Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system.
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- Macan — Macan Manufacturing · Class II
- Macan — Macan Manufacturing · Class II
- DIEGO ELITE — Gyrus Acmi, Inc. · Class II
- Macan — Macan Manufacturing · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- BOVIE — BOVIE MEDICAL CORPORATION · Class II
Cleared under the same submission
K020080 also covers:
- ART GT E1 Electrode Set — BONART CO., LTD.
- E1 Hand Piece — BONART CO., LTD.
- E1 Handpiece (S) — BONART CO., LTD.
- E1 INDIFFERENCE PLATE ∮ 6.3mm — BONART CO., LTD.
- E1 Indiference Plate — BONART CO., LTD.
- E1 Indifference plate — BONART CO., LTD.
- E1 electrode set (7 tips) — BONART CO., LTD.
- ELECTROSURGERY SYSTEM — BONART CO., LTD.
- GT1 Blade Type Electrode — BONART CO., LTD.
- GT2 Small Loop Electrode — BONART CO., LTD.
- GT3 Large Loop Electrode — BONART CO., LTD.
- GT4 Fine Wire Electrode — BONART CO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonart Co., Ltd.
Sources (1)
- FDA UDI 004918d6-12dc-4cd8-b1a9-95c8811a2215 33 fields · synced May 31, 2026