SL 115 Classic
The SL 115 Classic is an AC-powered slit lamp biomicroscope for examining the anterior segment of the eye, from the corneal surface to the posterior capsule. Eye care professionals use it…
The SL 115 Classic is an AC-powered slit lamp biomicroscope for examining the anterior segment of the eye, from the corneal surface to the posterior capsule. Eye care professionals use it to observe structural changes that may result from disease or trauma.
The slit controls allow horizontal adjustment from either side and vertical adjustment with a pinhole-type slit. Viewing is also possible with the slit illuminator in its middle position. These controls support observation of the eye’s structural features during examination.
Listed Item
The SL 115 Classic Slit Lamp is a AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment. The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.
Optional Documentation
The separate SL cam 5.0 digital imaging accessory can capture still images and video sequences of the anterior segment for documentation. Its imaging function is optional and does not control the slit lamp.
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 | Carl Zeiss Meditec Inc, United States |
|---|---|
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K133476 |
| Record published | 2016-04-25 |
| Record revised | 2022-12-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -10 to 55 °C; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SL 115 Classic | Weight: 9.75 kg (basic unit), 1.25 kg (head rest) | 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 |
|---|---|
| K173771 | 2018-08-24 |
| K162684 | 2017-05-31 |
| K170171 | 2017-04-06 |
| K161607 | 2017-02-23 |
| K143275 | 2015-07-10 |
| K141068 | 2014-09-09 |
| K133476 | 2014-02-12 |
| K122418 | 2013-04-12 |
| K101182 | 2010-11-03 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-10-23 | Class II | Software in the Use Environment | The user database delivered for download contained an erroneous value. Specifically the “aO” constant of the lens AMO Sensar AR40E is listed as “0.0” in the internal lens database of the IOLMaster. The correct value is -2.420. This could le | 4,907 units | 2014-04-17 |
| 2013-10-23 | Class II | Software in the Use Environment | The user database delivered for download contained an erroneous value. Specifically the “aO” constant of the lens AMO Sensar AR40E is listed as “0.0” in the internal lens database of the IOLMaster. The correct value is -2.420. This could le | 1,201 units | 2014-04-17 |
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.