Welch Allyn, Inc.
Welch Allyn 3.5 V Halogen HPX Ophthalmic Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11 820), Elite Streak Retinoscope (#18245), Fiber-Optic…
Welch Allyn 3.5 V Halogen HPX Ophthalmic Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11 820), Elite Streak Retinoscope (#18245), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 60-Minute Power Handle(s) — C-Cell Convertible, Hard Storage Case, Training Fundus Eyebox (#SM2383), Fixation Cards, C-Cell Battery Converter Accessory; Ni ckel-Cadmium (#72300) Battery; IEC Plug Type-A
7manufacturers in China registered for this device type
90catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Raish Meditech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Jiang XI BIG Vision Medical Technology Co., Ltd. | Ganzhou | Jiangxi | Manufacturer | 3 |
| Robotrak Technologies Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | HLI |
| Device type | Ophthalmoscope, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1570 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K930023 |
| Record published | 2022-08-08 |
| Record revised | 2025-03-26 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-02-21 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 901026 | In distribution | ||
| 901023 | In distribution | ||
| 901023 | In distribution | ||
| 901027 | In distribution | ||
| 901022 | In distribution | ||
| 901022 | In distribution | ||
| 901024 | In distribution | ||
| 901027 | In distribution | ||
| 901022 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901022 | In distribution | ||
| 901022 | In distribution | ||
| 901001 | 5 | In distribution | |
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901023 | In distribution | ||
| 901022 | In distribution | ||
| 901027 | In distribution | ||
| 901022 | In distribution | ||
| 901022 | In distribution | ||
| 901023 | In distribution | ||
| 901090 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901026 | In distribution | ||
| 901090 | In distribution | ||
| 901027 | In distribution | ||
| 901026 | In distribution | ||
| 901020 | In distribution | ||
| 901027 | In distribution | ||
| 901022 | In distribution | ||
| 901020 | In distribution | ||
| 901023 | In distribution | ||
| 901022 | In distribution | ||
| 901081 | In distribution | ||
| 901022 | In distribution | ||
| 901023 | In distribution | ||
| 901081 | In distribution | ||
| 901022 | In distribution | ||
| 901023 | In distribution | ||
| 901027 | In distribution | ||
| 901023 | In distribution | ||
| 901023 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | 5 | In distribution | |
| 901023 | In distribution | ||
| 901027 | In distribution | ||
| 901022 | In distribution | ||
| 901027 | In distribution | ||
| 901001 | In distribution | ||
| 901027 | In distribution | ||
| 901022 | In distribution | ||
| 901027 | In distribution | ||
| 901001 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901026 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901037 | In distribution | ||
| 901027 | In distribution | ||
| 901022 | In distribution | ||
| 901022 | In distribution | ||
| 901027 | In distribution | ||
| 901023 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901022 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901081 | In distribution | ||
| 901027 | In distribution | ||
| 901020 | In distribution | ||
| 901022 | In distribution | ||
| 901020 | In distribution | ||
| 901001 | Withdrawn | ||
| 901022 | Withdrawn | ||
| 901023 | Withdrawn | ||
| 901023 | Withdrawn | ||
| 901023 | Withdrawn | ||
| 901023 | Withdrawn | ||
| 901088 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901090 | Withdrawn | ||
| 901023 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901090 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amico Diagnostic Station | Amico Diagnostic Incorporated | 55 |
| iVue | Optovue, Inc. | 27 |
| Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 19 |
| Amico Diagnostic Rollstand | Amico Diagnostic Incorporated | 14 |
| iScan | Optovue, Inc. | 7 |
| zumax | Zumax Medical Co., Ltd. | 6 |
| Jedmed | Jedmed Instrument Company | 3 |
| RTVue XR Avanti | Optovue, Inc. | 3 |
| Amico Diagnostic Ophthalmoscope | Amico Diagnostic Incorporated | 3 |
| Laser Speckle Flowgraphy Lsfg-Navi | Softcare Co., Ltd. | 2 |
| Panoramic Ophthalmoscope | Optos Public Limited Company | 1 |
| 2.8v Specialist ophthalmoscope head & bulb | Keeler Ltd. | 1 |
Showing 12 of 46. All products under Ophthalmoscope, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K003376 | 2001-01-25 |
| K951210 | 1995-06-06 |
| K950461 | 1995-04-04 |
| K930023 | 1993-06-21 |
| K770768 | 1977-05-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.