Hand-held Dental X-ray System (HyperLight-M)
Device Facts
| Record ID | K260795 |
|---|---|
| Device Name | Hand-held Dental X-ray System (HyperLight-M) |
| Applicant | Changzhou Sifary Medical Technology Co., Ltd. |
| Product Code | EHD · Dental |
| Decision Date | Sep 14, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.1800 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
Device Story
HyperLight-M is a battery-operated, portable dental X-ray system for handheld use in hospitals, clinics, or dental offices. Device utilizes a DC generator to produce X-rays for diagnostic imaging via intra-oral receptors. Operator selects exposure time via control panel; system features fixed 70kV tube voltage and 3mA tube current. Includes Pb-filled acrylic scatter shield for radiation protection. Used by dentists/technicians to assist patients with special needs, nursing home residents, or those with limited mobility. Output is diagnostic X-ray image; healthcare provider uses image for clinical assessment and diagnosis. Benefits include portability and ease of use in non-traditional dental settings.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety, EMC, and performance testing (tube voltage, exposure time, imaging performance) per IEC 60601-1, IEC 60601-2-65, and 21 CFR 1020.30/31.
Technological Characteristics
Battery-operated portable DC X-ray generator. Fixed 70kV voltage, 3mA current. 159.5mm diameter, 13mm thick Pb-filled acrylic scatter shield. Total filtration ≥1.8mm Al. Source-to-skin distance 20cm. Embedded firmware on single-chip microcomputer. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-65, IEC 62304, ISO 14971.
Indications for Use
Indicated for use by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intra-oral receptors in adult and pediatric subjects.
Regulatory Classification
Identification
An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.
Predicate Devices
- HyperLight Portable X-ray Unit (K232068)
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
September 14, 2026
Changzhou Sifary Medical Technology Co., Ltd.
% Qingfei Pan
RA Engineer
# 26 Yandanghe Rd., Xinbei District
CHANGZHOU, JIANGSU 213000
CHINA
Re: K260795
Trade/Device Name: Hand-held Dental X-ray System (HyperLight-M)
Regulation Number: 21 CFR 872.1800
Regulation Name: Extraoral Source X-Ray System
Regulatory Class: Class II
Product Code: EHD
Dated: March 11, 2026
Received: August 12, 2026
Dear Qingfei Pan:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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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,
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# 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. | | K260795 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| Hand-held Dental X-ray System (HyperLight-M) | | | |
| Please provide your Indications for Use below. | | | ? |
| The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects. | | | |
| 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) | | ? |
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SIFARY
No. 26, Yandanghe Road, Xinbei District,
213000 Changzhou, Jiangsu, China
Tel/Fax: 0519-85962691
K260795
# 510(k) Summary
## 1. Submitter
| Manufacturer: | Changzhou Sifary Medical Technology Co., Ltd. No. 26 Yandanghe Road, Xinbei District, 213000 Changzhou, Jiangsu, China |
| --- | --- |
| Phone: | +86-158-61185968 |
| Contact Person: | Qingfei Pan (RA Engineer) |
| E-mail: | panqingfei@sifary.com |
| Date Prepared: | March 11, 2026 |
## 2. Device Classification
| Name of Device: | Hand-held Dental X-ray System (HyperLight-M) |
| --- | --- |
| Common Name: | Hand-held Dental X-ray System |
| Classification Name: | Extraoral source x-ray system |
| Regulation Number: | 872.1800 - Extraoral source x-ray system |
| Regulatory Class: | Class II |
| Product Code: | EHD |
| Review Panel: | Radiology |
## 3. Predicate Device
| Trade/Device Name: | HyperLight Portable X-ray Unit |
| --- | --- |
| Classification Name: | Extraoral source x-ray system |
| Regulation Number: | 872.1800 - Extraoral source x-ray system |
| Regulatory Class: | Class II |
| Product Code: | EHD |
| Review Panel: | Radiology |
| Manufacturer: | Changzhou Sifary Medical Technology Co., Ltd. |
| 510 (k) Number: | K232068 |
No reference devices were used in this submission.
## 4. Device Description
HyperLight-M Hand-held Dental X-ray System is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing digital imaging techniques. The HyperLight-M Hand-held Dental X-ray System is designed for use in hospital environments, clinics or dental offices where appropriate safeguards are implemented.
The HyperLight-M Hand-held Dental X-ray System is an X-ray device with a DC generator. To make the system as simple as possible for the operator, HyperLight-M uses a fixed tube voltage of 70kV and a fixed tube current of 3mA. The only operator-adjustable parameter is the exposure time.
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SIFARY
No. 26, Yandanghe Road, Xinbei District,
213000 Changzhou, Jiangsu, China
Tel/Fax: 0519-85962691
This adjustment can be quickly accomplished through the user-friendly control panel.
This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The portable x-ray device is a choice model to assist doctors with special need patients, nursing home patients and patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.
## **5. Indications for Use**
The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
## **6. Intended Use**
Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
## **7. Intended patient population**
The Hand-held Dental X-ray System is suitable for both adult and pediatric subjects.
The selection of the type of patient is at the discretion of the dental professional; however, we recommend using the "Child" function, for children up to 12 years old. For important information related with radiation safety in pediatric imaging please check the following link:
https://www.imagegently.org/Procedures/Dental#35771808-safety-
### Considerations for Pediatric Use
- Image only when there is a clear medical benefit.
- Image only the indicated area.
- Use the lowest amount of radiation for adequate imaging.
- Try to use always short exposure times, large source image distance values and immobilizing devices.
- Avoid multiple scans and use alternative diagnostic studies
## **8. Comparison of Technological Characteristics with the Predicate Device**
The comparison between the overall specifications of predicate device (HyperLight) and the new device (HyperLight-M) is shown in the following table.
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SIFARY
No. 26, Yandanghe Road, Xinbei District,
213000 Changzhou, Jiangsu, China
Tel/Fax: 0519-85962691
| Device characteristic | Subject DeviceHyperLight-M Hand-held Dental X-ray System | Predicate DeviceHyperLight Portable X-ray Unit (K232068) |
| --- | --- | --- |
| 510(k) Owner | Changzhou Sifary Medical Technology Co., Ltd. | Changzhou Sifary Medical Technology Co., Ltd. |
| Classification & Product Code | 872.1800; EHD | 872.1800; EHD |
| Intended Use | Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. | Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. |
| Indications for Use | The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects. | The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects. |
| Size | 11.53” x 6.28” x 12.48” | 11.85” x 4.58” x 9.97” |
| Source to Skin Distance | 20 cm | 20 cm |
| Cone Diameter | 5.7 cm | 5.7 cm |
| User Interface | Left-right buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size, and tooth selection icons on an LCD display. | Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size, and tooth selection icons on an LCD display. |
| Backscatter radiation protection | 159.5mm dia. 13mm thick Pb-filled acrylic plastic scatter shield | 159.5mm dia. 13mm thick Pb-filled acrylic plastic scatter shield |
| Exposure switch | Exposure trigger at the lower front area of the main body or remote switch. | Exposure trigger at the lower front area of the main body or remote switch. |
| Exposure Time | 0.02 ~ 2.0 seconds | 0.02 ~ 2.0 seconds |
| Time Accuracy | ±5% or ±20ms whichever is larger | ±5% or ±20ms whichever is larger |
| Tube Current | 3mA fixed | 2.5mA fixed |
| Tube Voltage | 70kVp fixed | 65kVp fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | 1:30 | 1:30 |
| Total Filtration | ≥1.8mm Al | ≥1.8mm Al |
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SIFARY
No. 26, Yandanghe Road, Xinbei District,
213000 Changzhou, Jiangsu, China
Tel/Fax: 0519-85962691
| Performance Standards | IEC 60601-1 | IEC 60601-1 |
| --- | --- | --- |
| | IEC 60601-1-2 | IEC 60601-1-2 |
| | IEC 60601-1-3 | IEC 60601-1-3 |
| | IEC 60601-1-6 | IEC 60601-1-6 |
| | IEC 60601-2-65 | IEC 60601-2-65 |
| | IEC 62304 | IEC 62304 |
| | IEC 62366 | IEC 62366 |
| | ISO 14971 | ISO 14971 |
| | IEC 61223-3-4 | IEC 61223-3-4 |
The above comparison table shows that the subject and predicate devices have substantially similar technology characteristics. Slight differences show up in the size, user interface, tube current and tube voltage. All of the parameters of the subject device comply with 21 CFR 1020.30 & 1020.31 and related IEC standards. The differences of the device do not raise new issues of safety and effectiveness.
## 9. Non-clinical Performance Data
The following non-clinical performance data were provided in support of the substantial equivalence determination.
### Biocompatibility
For the biocompatibility of the parts that can come into contact with the patient, ISO 10993-1:2018 “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” has been considered. During clinical use, the Disposable Sleeve is used to cover the sensor, which is already enclosed by the Sensor Sleeve when M-TECH function is enabled. The sensor assembly can be completely wrapped by the Disposable Sleeve, whose strength has already been verified. The patient gently bites the sensor assembly, so only the Disposable Sleeve will come into direct contact with the patient’s oral mucosa. The Disposable Sleeve is made of Polyethylene (PE). The battery of testing included the following tests:
- Cytotoxicity
- Irritation
- Sensitization
According to the test results, no biocompatibility problem has been observed.
### Electrical Safety and Electromagnetic Compatibility (EMC)
The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:
• IEC 60601-1 Edition 3.2 2020-08
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 [Incl. AMD2:2021]
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SIFARY
No. 26, Yandanghe Road, Xinbei District,
213000 Changzhou, Jiangsu, China
Tel/Fax: 0519-85962691
- ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]
- IEC TR 60601-4-2 Edition 1.0 2016-05
- IEC 60601-1-3 Edition 2.2 2021-01
- IEC 60601-2-65 Edition 1.2 2021-05
- IEC 60601-1-6 Edition 3.2 2020-07
### **Software Verification and Validation Testing**
The software of HyperLight-M takes the single chip microcomputer as the carrier, which is solidified in the product as a firmware during production. It works in conjunction with the hardware to perform the basic functions of the Hand-held Dental X-ray System and belongs to the embedded software. Software verification and validation testing has been conducted and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Content of Premarket Submissions for Device Software Functions”, and “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. The software documentation level for this device was considered as Basic Documentation Level, since a failure or flaw of software function would not present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures.
### **Bench Testing**
Performance bench testing was conducted as part of design control to ensure the substantial equivalence of HyperLight-M to the predicate device. The testing was performed according to the requirements of 21 CFR Part 1020.30, 1020.31, IEC 61223-3-4 and IEC 60601-2-65. The representative indicators, such as tube voltage, exposure time and imaging performance were measured. The results demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.
### **Clinical Considerations**
Clinical data is NOT required for a finding of substantial equivalence.
## **10. Conclusions**
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Changzhou Sifary Medical Technology Co., Ltd., concludes that Hand-held Dental X-ray System (model: HyperLight-M) is safe and effective and substantially equivalent to predicate device as described herein.
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