Kowa SL-17
The Kowa SL-17 is a handheld slit lamp biomicroscope for examining the front of the eye. It provides illumination, magnification and observation from the corneal epithelium through to the…
The Kowa SL-17 is a handheld slit lamp biomicroscope for examining the front of the eye. It provides illumination, magnification and observation from the corneal epithelium through to the posterior lens capsule.
The battery powered instrument combines viewing and illumination optical systems with a stand. Its noninvasive examination supports assessment of structural changes in the anterior eye segment.
Listed Item
KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Clinical Examination
The SL-17 is used to aid diagnosis of diseases or trauma affecting anterior eye structures. Its optical system gives the examiner an illuminated, magnified view of those structures.
Who Else Makes It
Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| 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 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Kowa Co., Ltd., Japan |
|---|---|
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| 510(k) | K133755 |
| Record published | 2016-09-16 |
| Record revised | 2022-12-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -15 to 55 °C; Storage environment humidity 10 to 95 % RH; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 90 % RH |
| Sizes | Height 220 mm; depth 95 mm; width 220 mm; weight 745 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SL170K/A | Height 220 mm | In distribution |
| SL170K/P | Height 220 mm | In distribution |
| SL170K/W | Width 220 mm | In distribution |
| SL170K/G | Height 220 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MediWorks | Shanghai Mediworks Precision Instruments Co., Ltd. | 30 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 24 |
| Marco | Takagi Seiko Co., Ltd. | 17 |
| Gilras | U.S. Ophthalmic, L.L.C. | 16 |
| Visionix | Luneau Technology Operations | 15 |
| LED Slit Lamp | Right MFG. Co., Ltd. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 12 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 12 |
| Inami | Inami & Co., Ltd. | 11 |
| Zoom Slit Lamp | Right MFG. Co., Ltd. | 8 |
| Slit Lamp BQ 900 | Haag-Streit AG | 8 |
| PolyLock Small Bone | Fusion Orthopedics, LLC | 7 |
Showing 12 of 168. All products under Biomicroscope, Slit-Lamp, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222372 | 2022-11-21 |
| K133755 | 2014-03-11 |
| K063640 | 2006-12-18 |
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.