SLIT LAMP SL-D4 (Type: LED)

{0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION September 18, 2026 Topcon Corporation % Maureen O'connell President O'Connell Regulatory Consultants, Inc. 44 Oak St. Stoneham, Massachusetts 02180 Re: K262637 Trade/Device Name: SLIT LAMP SL-D4 (Type: LED) Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: July 29, 2026 Received: July 29, 2026 Dear Maureen O'connell: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262637 - Maureen O'connell Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). {2} K262637 - Maureen O'connell Page 3 Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # BRADLEY S. CUNNINGHAM -S CAPT Bradley Cunningham, MSE, RAC Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262637 | ? | | Please provide the device trade name(s). | | ? | | SLIT LAMP SL-D4 (Type: LED) | | | | Please provide your Indications for Use below. | | ? | | The Slit Lamp SL-D4 (Type: LED) is an AC-powered slitlamp biomicroscope 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. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K262637 ## 510(k) SUMMARY Traditional 510(k) TOPCON CORPORATION SLIT LAMP SL-D4 (Type: LED) ## GENERAL INFORMATION Submitter's Information: TOPCON CORPORATION 75-1 Hasunuma-cho, Itabashi-ku Tokyo, 174-8580, Japan Contact Person: Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street, Stoneham, MA 02180 Telephone: 978-207-1245 E-mail: maureen@oconnellregulatory.com Date Prepared: July 31, 2026 ## DEVICE INFORMATION SUBJECT DEVICE Name of Device: SLIT LAMP SL-D4 (Type: LED) Classification: Class II Classification Name: 21 CFR 886.1850 (AC-powered slitlamp biomicroscope) Product Code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered) Traditional 510(k) SL-D4 (Type: LED) Topcon Corporation Page 1 of 7 {5} K262637 # **PREDICATE DEVICE** Company: TOPCON CORPORATION Device: Slit Lamp SL-D701 510(k) No.: K133667 Classification Name: 21 CFR 886.1850 (AC-powered slitlamp biomicroscope) Product Code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered) # **BRIEF DEVICE DESCRIPTION** The SLIT LAMP SL-D4 (Type: LED) is an AC-powered slit lamp biomicroscope 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. Illumination light emitted from the illumination optical system illuminates the eye and its associated structures, while the binocular stereoscopic microscope enables magnified and stereoscopic observation. In addition, observation images (static or video images) can be captured, output, and stored, together with associated information (such as patient/device/ photographing information) using either: - The DIGITAL CAMERA UNIT DC-4 and its dedicated software, Ez Capture for DC-4 in combination with a commercially available personal computer (hereafter referred to as "PC"), or - The TV Relay Lens or TV Attachment in combination with a commercially available camera and a commercially available PC. Also, The SL-D4 (Type: LED) has tonometer mounts as its accessories to attach a commercially available tonometer. Traditional 510(k) SL-D4 (Type: LED) Topcon Corporation Page 2 of 7 {6} K262637 ## INTENDED USE / INDICATIONS FOR USE The SLIT LAMP SL-D4 (Type: LED) is an AC-powered slitlamp biomicroscope 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. ## NON-CLINICAL TEST RESULTS Non-clinical evaluation and testing results according to the following standards were submitted. The SLIT LAMP SL-D4 (Type: LED) satisfied the requirements. - ANSI AAMI ES60601-1 (harmonized with IEC 60601-1) - IEC60601-1-2 - ISO15004-1 - ANSI Z80.36 - ANSI Z80.37 ## SUBSTANTIAL EQUIVALENCE The subject device, the SLIT LAMP SL-D4 (Type: LED), is substantially equivalent to the predicate device because the intended use/indications for use, operation principle and technological characteristics of the SLIT LAMP SL-D4 (Type: LED) are similar or equivalent to those of the predicate device as shown in Table A in the following pages. Traditional 510(k) SL-D4 (Type: LED) Topcon Corporation Page 3 of 7 {7} K262637 Table A Substantial Equivalence | Model Number | SL-D4 (Type: LED) (Subject device) | SL-D701 (Predicate device) | Substantial Equivalence Discussion | | --- | --- | --- | --- | | Trade Name | SLIT LAMP SL-D4 (Type: LED) | Slit Lamp SL-D701 | N/A | | 510(k) submitter/holder | TOPCON Corporation | TOPCON Corporation | N/A | | 510(k) Number | Not yet known | K133667 | N/A | | Product code | HJO | HJO | Same | | Regulation No. | 21 CFR 886.1850 | 21 CFR 886.1850 | Same | | Product class | II | II | Same | | Intended Use /Indications for Use | The SLIT LAMP SL-D4 (Type: LED) is an AC-powered slitlamp biomicroscope 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. | The Slit Lamp SL-D701 is an AC-powered slitlamp biomicroscope 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. | Same | | Operating principle | **Observation** Illumination light emitted from the illumination optical system illuminates the observation area, and the binocular stereo microscope unit magnifies the observation field. **Photography and video recording** Illumination light emitted from the illumination optical system illuminates the observation area. A camera (such as a commercially available digital still camera or video camera or the "DIGITAL CAMERA UNIT DC-4" provided as an accessory of this device) captures the magnified image observed through the device's binocular stereo microscope. | Illuminates the observed part by the illumination light emitted from the illumination optical system and allows enlargement observation by binocular stereoscopic microscope. A commercially available still camera or video camera and the "DIGITAL CAMERA UNIT DC-4" can be used in combination with SL-D701 for photography of images. | Substantially Equivalent | | Technological Characteristics (Device Specification, Critical Optical Elements) | **Microscope unit** Magnification: Drum, 5-step magnification Magnification steps: 6, 10, 16, 25, 40 Overall magnification (actual vision field): 6.37 (φ35.1mm) 9.94 (φ22.5mm) 15.87 (φ14.1mm) 25.37 (φ8.8mm) 39.62 (φ5.6mm) | **Microscope unit** Magnification: Drum, 5-step magnification Magnification steps: 6, 10, 16, 25, 40 Overall magnification (actual vision field): 6.37 (φ35.1mm) 9.94 (φ22.5mm) 15.87 (φ14.1mm) 25.37 (φ8.8mm) 39.62 (φ5.6mm) | Substantially Equivalent | Traditional 510(k) SL-D4 (Type: LED) Topcon Corporation Page 4 of 7 {8} K262637 | Model Number | SL-D4 (Type: LED) (Subject device) | SL-D701 (Predicate device) | Substantial Equivalence Discussion | | --- | --- | --- | --- | | | Eyepiece lens: Magnification 12.5x -5D to +5D Binocular tubes PD adjustment: 55 to 78mm **Illumination unit** Light source: LED Illumination field: Slit width: 0 to 14mm, can be altered gradually (14mm=circle) Slit length: 1 to 14mm, can be altered gradually (14mm=circle) Aperture diameter: φ14mm, 10mm, 5mm, 1mm, 0.3mm Slit direction: Vertical to horizontal can be altered gradually Side swing Filter: Exciter filter Red-free filter Color conversion filter UV cut filter IR cut filter Yellow filter unit **Base unit** Forward-backward movement: 90mm Right-left movement: 100mm Vertical movement: 30mm Fine movement forward-backward/ right-left: 12mm **Chinrest unit** Vertical movement: 80mm | Eyepiece lens: Magnification 12.5x -5D to +5D Binocular tubes PD adjustment: 55 to 78mm **Illumination unit** Light source: LED Illumination field: Slit width: 0 to 14mm, can be altered gradually (14mm=circle) Slit length: 1 to 14mm, can be altered gradually (14mm=circle) Aperture diameter: φ14mm, 10mm, 5mm, 1mm, 0.2mm Slit direction: Vertical to horizontal can be altered gradually Filter: Exciter Filter Red-free Filter Amber Filter UV cut Filter IR cut Filter Yellow filter unit Blue Filter ND filter (13% transmission) **Base unit** Forward-backward movement: 90mm Right-left movement: 100mm Vertical movement: 30mm Fine movement forward-backward/ right- left: 12mm **Chinrest unit** Vertical movement: 80mm | | Traditional 510(k) SL-D4 (Type: LED) Topcon Corporation Page 5 of 7 {9} K262637 | Model Number | SL-D4 (Type: LED) (Subject device) | SL-D701 (Predicate device) | Substantial Equivalence Discussion | | --- | --- | --- | --- | | **Data Collection and/or Display Systems** | Images acquired by the Digital Camera Unit DC-4 can be displayed on a PC screen and can be reviewed and stored using Ez Capture for DC-4. | Images acquired by the Digital Camera Unit DC-4 can be displayed on a PC screen and can be reviewed and stored using Ez Capture for DC-4. | Substantially Equivalent | | **Flammability of Materials** | Complies with IEC 60695-2-11. | Complies with IEC 60695-2-11. | Substantially Equivalent | | **Maximum Temperature of Parts of the Device held by the Operator or accessible to the Patient** | Complies with IEC 60601-1, Clause 11.1.1. | Complies with IEC 60601-1, Clause 11.1.1. | Substantially Equivalent | | **Brightness Controls** | Complies with ANSI Z80.36. | Complies with ISO15004-2. | Substantially Equivalent | | **Conformity Standards** | ANSI AAMI ES60601-1 (harmonized with IEC 60601-1) IEC60601-1-2 ISO15004-1 ANSI Z80.36 ANSI Z80.37 | IEC60601-1 IEC60601-1-2 ISO15004-1 ISO15004-2 ISO 10939 | Substantially Equivalent | Traditional 510(k) SL-D4 (Type: LED) Topcon Corporation Page 6 of 7 {10} K262637 ## CONCLUSION The results of the non-clinical tests demonstrate that the SLIT LAMP SL-D4 (Type: LED) is as safe and effective as the legally marketed device. Therefore, the SLIT LAMP SL-D4 (Type: LED) is substantially equivalent to the predicate device. Traditional 510(k) SL-D4 (Type: LED) Topcon Corporation Page 7 of 7