Identity
- Trade Name
- Honan Intraocular Pressure Reducer FDA UDI
- Generic Name
- Intraocular pressure-reducing compression system FDA UDI
- Device Name
- GAUGE, CASE, TUBING, WITH REUSABLE BELLOWS & HEADBAND FDA UDI
- Model / Reference
- 2050 FDA UDI
- Description
- GAUGE, CASE, TUBING, WITH REUSABLE BELLOWS & HEADBAND FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851607007004 FDA UDI
- 510(k) Number
- K820526 FDA UDI
- FDA Product Code
- LCC FDA UDI
- GMDN Term
- Intraocular pressure-reducing compression system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4610 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
Yes
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Intraocular pressure-reducing compression system
The Honan Intraocular Pressure Reducer (IOPR) is a reliable and efficient device for reducing intraocular pressure (IOP), allowing for smoother and safer ophthalmic surgery. By using an inflatable bellows, air pump, pressure indicator, and tubing, this device helps to create a temporary reduction in IOP, making it ideal for patients undergoing eye surgeries. Developed by LEBANON CORP, the Honan IOPR is designed to be reusable and has been thoroughly tested for safety and efficacy.
Similar devices
Also classified as Intraocular pressure-reducing compression system.
- JEDMED — JEDMED Instrument Company · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- HONAN BALLOON HEADBAND (NO LATEX) — Katena Products, Inc. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
Cleared under the same submission
K820526 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lebanon Corp, The
Sources (1)
- FDA UDI c35138cf-51f6-48ea-970d-9d43cb852517 34 fields · synced Jul 27, 2026