← Product Code [NBL](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/NBL) · K252464

# Surgical Microscope (OMS2360, OMS2380) (K252464)

_Zumax Medical Co., Ltd. · NBL · Apr 28, 2026 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/NBL/K252464

## Device Facts

- **Applicant:** Zumax Medical Co., Ltd.
- **Product Code:** [NBL](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/NBL.md)
- **Decision Date:** Apr 28, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.1745
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for Use

The surgical microscope is intended for use by qualified dental professionals in hospital operating rooms and hospital clinical settings to provide illumination and magnification of the surgical area and for the support of visualization in surgical procedures or examinations (except ophthalmic surgeries). It optionally enables handling of light curing dental composite resins and aids in reducing specular light reflections and enhances contrast between red tissue and blood. The fluorescence mode is intended for use by qualified dental professionals in hospital clinical settings as an adjunctive aid to assist in the detection of dental caries.

## Device Story

Surgical microscope (OMS2360, OMS2380) provides illumination and magnification for dental procedures; features fluorescence mode using 405nm blue LED light to excite bacteria for caries detection. Operated by dental professionals in hospital settings; provides visual output via microscope optics. Fluorescence mode acts as adjunctive diagnostic aid; enhances contrast between red tissue and blood; reduces specular reflections. Device includes super balancing arm and microscope body; installed via floor, ceiling, wall, or fixed ground mounts. Benefits include improved visualization and uninterrupted workflow during dental examinations and surgeries.

## Clinical Evidence

Bench testing only. Includes photobiological safety (IEC 62471), electrical safety/EMC (IEC 60601-1/2), and performance testing (ISO 10936-1). Concurrence evaluation performed on clinical images from phantoms/patients demonstrated equivalent diagnostic capability to predicate.

## Technological Characteristics

Fluorescence-based dental microscope; 405nm LED light source. Materials/specs comply with ISO 10936-1, IEC 60601-1, IEC 62471, IEC 62366-1, IEC 80601-2-60. Working distance 200-450mm. Power 40VA. Mechanical control for light/filters; no wireless connectivity.

## Regulatory Identification

A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.

## Special Controls

*Classification.* Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.

1. restrictions on the sale, distribution, and use of the device to prescription use in accordance with 21 CFR 801.109;

2. clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and

3. labeling that includes detailed use instructions with precautions that urge users to (i) read and understand all directions before using the device, (ii) store probe tips under proper conditions, (iii) properly sterilize the emitter-detector handpiece before each use, and (iv) properly maintain and handle the instrument in the specified manner and condition.

## Predicate Devices

- Fluorescence Mode ([K171007](/device/K171007.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 28, 2026

Zumax Medical CO., LTD
% Mike Gu
RA Director
Suzhou Device Innovation Medical Consulting Co., Ltd
Room 1001, Building 19, No. 3188 Renmin Road
Suzhou, Jiangsu 215000
CHINA

Re: K252464
Trade/Device Name: Surgical Microscope (OMS2360, OMS2380)
Regulation Number: 21 CFR 872.1745
Regulation Name: Laser fluorescence caries detection device
Regulatory Class: Class II
Product Code: NBL, EPT
Dated: June 25, 2025
Received: August 6, 2025

Dear Mike Gu:

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.

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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" (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). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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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,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF

|  DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.  |
| --- | --- |
|  510(k) Number (if known) K252464  |   |
|  Device Name Surgical Microscope  |   |
|  Indications for Use (Describe) The surgical microscope is intended for use by qualified dental professionals in hospital operating rooms and hospital clinical settings to provide illumination and magnification of the surgical area and for the support of visualization in surgical procedures or examinations (except ophthalmic surgeries). It optionally enables handling of light curing dental composite resins and aids in reducing specular light reflections and enhances contrast between red tissue and blood. The fluorescence mode is intended for use by qualified dental professionals in hospital clinical settings as an adjunctive aid to assist in the detection of dental caries.  |   |
|  Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)  |   |
|  CONTINUE ON A SEPARATE PAGE IF NEEDED.  |   |
|  This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*  |   |
|  The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov  |   |
|  "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."  |   |

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K252464

Section 038: 510(k) Summary

Surgical Microscope

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# 510(k) Summary

K number: K252464

## I, Submitter Information

Name: Zumax Medical CO., LTD.
Address: 5 Zhiying Street, Suzhou New District, Suzhou, Jiangsu, China 215129
Telephone: +86-512-66650512-504
Fax: +86-512-66909655
Contact person: Alfred Hee
Email: alfred.hee@zumaxmedical.com

## II, Date Prepared

June 30, 2025

## III, Device Information

Trade name: Fluorescence Mode
Common name: Dental Fluorescence Examination Device
Regulation class: Class II
Regulation number: 21 CFR 872.1745
Review Panel: Dental
Product code: NBL

## IV, Predicative Device

510(k): K171007
Device name: Fluorescence Mode
Manufacturer: Carl Zeiss Suzhou Co., Ltd

## V, Device Description

Surgical microscopes OMS2360, OMS2380 can be installed in floor stand ceiling mounted, wall mounted and fixed ground. The installation methods are electrically identical, and the components include microscope main body, super balancing arm, second arm, and first arm, and the difference is that the installed structural parts are different.

The Fluorescence Mode is an accessory to the OMS2360, OMS2380 surgical microscope to utilize a kind of LED light that illuminates the tooth surfaces in the visible domain in the blue light region with wavelength 405nm.

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## VI, Indication for Use

The surgical microscope is intended for use by qualified dental professionals in hospital operating rooms and hospital clinical settings to provide illumination and magnification of the surgical area and for the support of visualization in surgical procedures or examinations (except ophthalmic surgeries). It optionally enables handling of light curing dental composite resins and aids in reducing specular light reflections and enhances contrast between red tissue and blood.

The fluorescence mode is intended for use by qualified dental professionals in hospital clinical settings as an adjunctive aid to assist in the detection of dental caries.

## VII, Predicate Comparison

Table 1: Substantial Equivalence Table

|  Attribute | Subject device | Predicate device | Comments  |
| --- | --- | --- | --- |
|  510(k) number | Not applicable | K171007 | /  |
|  Intended use | The surgical microscope is intended for use by qualified dental professionals in hospital operating rooms and hospital clinical settings to provide illumination and magnification of the surgical area and for the support of visualization in surgical procedures or examinations (except ophthalmic surgeries). It optionally enables handling of light curing dental composite resins and aids in reducing specular light reflections and enhances contrast between red tissue and blood. The fluorescence mode is intended for use by qualified dental professionals in hospital clinical settings as an adjunctive aid to assist in the detection of dental caries. | The Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries. | Same  |
|  Indication for use | The surgical microscope is intended for use by qualified dental professionals in hospital operating rooms and hospital clinical settings to provide illumination and magnification of the surgical area and for the support of visualization in surgical procedures or examinations (except ophthalmic surgeries). It optionally enables handling of light curing dental composite resins and aids in reducing specular light | The Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries. | Same  |

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|   | reflections and enhances contrast between red tissue and blood. The fluorescence mode is intended for use by qualified dental professionals in hospital clinical settings as an adjunctive aid to assist in the detection of dental caries. |  |   |
| --- | --- | --- | --- |
|  Device Classification Name | Laser Fluorescence Caries Detection | Laser Fluorescence Caries Detection | Same  |
|  Generic Common Name | Dental Fluorescence Examination Device | Dental Fluorescence Examination Device | Same  |
|  Classification Product Code | NBL | NBL | Same  |
|  Class | II | II | Same  |
|  Intended user | No special requirements | No special requirements | Same  |
|  Technology | Fluorescence technology to aid in the detection of carious lesions | Fluorescence technology to aid in the detection of carious lesions | Same  |
|  Mode of Operation | Excites bacteria to fluoresce | Excites bacteria to fluoresce | Same  |
|  Detection Wavelength | 405 nm | 405 nm | Same  |
|  Device Operating Feature | Microscope with built-in feature provides visualization and an uninterrupted workflow | Dental microscope with built-in feature provides visualization and an uninterrupted workflow | Same  |
|  Light intensity | ≥90,000 lx | 97540 lx | Similar, analysis  |

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|  Attribute | Subject device |   | Predicate device |   | Comments  |
| --- | --- | --- | --- | --- | --- |
|   | (at the working distance of 200mm) |   | (at the working distance of 200mm) |   | 1  |
|  theWorking distance | 200-450 mm |   | 200-430 mm |   | Similar, analysis 2  |
|  Power source | 40VA |   | 120VA |   | Similar, analysis 3  |
|  Environmental conditions | Ambient requirements for operation |   | Ambient requirements for operation |   | Similar, analysis 4  |
|   |  Designation | Value | Designation | Value  |   |
|   |  Temperature | + 10°C ... +40°C | Temperature | + 10°C ... +40°C  |   |
|   |  Rel. humidity | 30% ... 75% | Rel. humidity | 30% ... 75%  |   |
|   |  Air pressure | 700 hPa ... 1060 hPa | Air pressure | 700 hPa ... 1060 hPa  |   |
|   |  Ambient requirements for transport and storage |   | Ambient requirements for transport and storage  |   |   |
|   |  Designation | Value | Designation | Value  |   |
|   |  Temperature | - 40°C ... + 55°C | Temperature | - 40°C ... + 70°C  |   |
|   |  Rel. humidity | 10% ... 80% | Rel. humidity | 10% ... 90%  |   |
|   |  Air pressure | 500 hPa ... 1060 hPa | Air pressure | 500 hPa ... 1060 hPa  |   |
|  Standards | ISO 10936-1:2000
IEC 60601-2:2014
IEC 60601-1:2005
IEC 62471:2006
IEC 62366-1:2015
IEC 60601-1-6:2020
IEC80601-2-60:2019 |   | ISO 10936-1:2000
IEC 60601-2:2014
IEC 60601-1:2005
IEC 62471:2006
IEC 62366-1:2015 |   | Same  |
|  Software | Software of Surgical Microscope:
• Video Control (Only applicable to the video accessory which is optional before leaving the factory) |   | Software of Surgical Microscope:
• Light Source Control
• Filter Control
• Video Control
• Wi-Fi Module: Firmware processes network communication |   | Similar, analysis 5  |

Analysis 1: Test shows that the light intensity of the subject product is slightly higher than predicate one. The light source of the subject product and predicate product both meet the requirements of IEC 62471:2006/EN 62471: 2008 Photobiological safety of lamps and lamp systems. Also, the performance of the two products meet the requirements of ISO 10936- 1:2000 Optics and photonics – Operation microscopes – Part 1: Requirements and test methods.

The light source is intended for illumination of the surgical area, the difference in

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light intensity does not affect the performance and clinical use.

Analysis 2: The working distance of the subject product contains and is better than predicate product. This difference does not affect the performance of the product.

Analysis 3: Compared with subject device and predicate device, there is a difference in the power of the devices, but both can drive the devices to achieve their respective functions. The difference does not affect the safety and effectiveness of the device.

Analysis 4: Compared with subject device and predicate device, there is a difference in the temperature for transport and storage. The difference does not affect the safety and effectiveness of the device.

Analysis 5: Software of the subject product is used to control the video, the light source and filter are controlled are mechanically controlled, and there is no wireless module in the subject device.

## VIII, Non-clinical Performance Testing

- Light safety testing in accordance with IEC 62471:2006.
- Electrical safety Testing and EMC in accordance with IEC60601-1 and IEC60601-1-2.
- Performance test for the fluorescence mode base on surgical microscope in accordance with ISO 10936-1:2000.

Additionally Conducting a concurrence evaluation on a certain number of clinical images from the same phantom or patients and reporting the results. The results show the ability of the device to provide images with equivalent diagnostic capability to those of the cleared predicate devices.

The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.

## IX, Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/NBL/K252464](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/NBL/K252464)

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