Bausch + Lomb
Tnmtr Allen-Schiotz Plngr Retr
5manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HKY |
| Device type | Tonometer, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1930 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-12-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E5754 D | In distribution | |
| E5755 | In distribution | |
| E5754 B | In distribution | |
| E5754 | In distribution | |
| E5754 C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tonometer AT 900 | Haag-Streit AG | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Ocu-Film® +” | Reichert Inc. | 5 |
| AccuTip Cover | Accutome, Inc. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 4 |
| Applanation Tonometer | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 3 |
| Icare ic200 | Icare Finland Oy | 3 |
| Marco | Takagi Seiko Co., Ltd. | 2 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 2 |
| iCare PATIENT2 | Icare Finland Oy | 2 |
| Tonometer AT 870 | Haag-Streit AG | 2 |
| Takagi | Takagi Seiko Co., Ltd. | 2 |
Showing 12 of 71. All products under Tonometer, Manual
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K011199 | 2001-07-02 |
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.