(209 days)
The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Heager Medical Laser Family generates a 980nm wavelength laser to act on a target tissue to achieve hemostasis, ablation, and coagulation of the target tissue. The Heager Medical Laser Family generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Heager Medical Laser Family has following characteristics:
- Dual wavelengths
- Temperature monitoring system
This document is a 510(k) clearance letter for a medical laser device, not a study report. Therefore, it does not contain the specific details about acceptance criteria and study results you requested in the format typically found in a clinical or performance study.
Based on the provided FDA 510(k) clearance letter for the Heager Medical Laser Family, here's what can be extracted and what information is not available within this document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative, measurable way for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices based on technical specifications and adherence to recognized electrical and safety standards.
The "reported device performance" is primarily presented as technical specifications and compliance with safety standards rather than clinical performance metrics.
| Feature/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Wavelength | Within specified range | 980nm±20nm, 1470nm±20nm |
| Laser Output Power | Within specified range | 980nm±20nm cw 20W, 1470nm±20nm cw 15W |
| Aiming Beam | Within specified range | Diode laser of 650nm, power Max. 10mW, adjustable brightness |
| Pulse Width Range | Appropriately wide for intended use, similar to reference devices | 0.1s - 10s (stepping 0.1s) |
| Electrical Safety | Compliance with IEC 60601-1 ed. 3.2, IEC 60825-1 ed. 2.0, IEC 60601-2-22 ed. 4.0 | Complies with IEC 60601-1:2005+A1:2012+A2:2020, IEC 60825-1:2014, IEC 60601-2-22:2019 (Note: IEC 60825-1 is listed as ed 2.0 in section 7.0 and 2014 in section 12, need clarification if 2014 is equivalent to or supersedes 2.0) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 ed. 4.1 | Complies with IEC 60601-1-2:2014+A1:2021 |
| User Interface (IEC 60601-1-6) | Compliance with IEC 60601-1-6 ed. 3.2 | Complies with IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
| Biocompatibility of contact materials (implied for fiber) | Compliance with ISO 10993 series | Fibers must meet ISO 10993 series standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. As this is a 510(k) for a laser surgical instrument, the primary "test set" would be the device itself tested against engineering and safety standards, not a clinical data set in the way an AI/diagnostic device would have. The document explicitly states: "No clinical study implemented for the Diode laser therapy device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available. Given that "No clinical study implemented," there would be no ground truth established by experts in a clinical context for the purpose of a study demonstrating effectiveness. The "ground truth" here is the adherence to engineering standards and technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. Adjudication methods are typically associated with clinical studies involving human observers or raters, which were not conducted for this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not available. This is a laser surgical instrument, not an AI software/diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not available. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this 510(k) context is primarily compliance with recognized electrical, safety, and performance standards (e.g., IEC standards) and technical specifications of the device, demonstrated through non-clinical testing.
8. The sample size for the training set
This information is not applicable and not available. There is no "training set" in the context of an AI/machine learning model for this type of laser device 510(k) submission.
9. How the ground truth for the training set was established
This information is not applicable and not available for the same reason as point 8.
FDA 510(k) Clearance Letter - Heager Medical Laser Family
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.08.00
Silver Spring, MD 20993
www.fda.gov
August 26, 2025
Heager Gmbh
℅ Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China
Re: K250261
Trade/Device Name: Heager Medical Laser Family (Sabrina/Adolf)
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX
Dated: August 14, 2025
Received: August 14, 2025
Dear Boyle Wang:
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
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K250261 - Boyle Wang Page 2
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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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).
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K250261 - Boyle Wang 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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.08.26 09:38:59 -04'00'
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
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.
Submission Number (if known): K250261
Device Name: Heager Medical Laser Family (Sabrina/Adolf)
Indications for Use (Describe)
The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
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."
Page 5
510(k) Summary K250261
1.0 Submitter's information
Name: Heager Gmbh
Address: Friedrich-Ebert-Straße 111 - 117, 42781 Haan, Germany
Phone Number: +49 21293743770
Contact: Wolfgang Christiani
Email: heagergmbh@gmail.com
Date of Preparation: Jan.23, 2025
Prior submissions
This is the first submission, there is no prior submission.
Designated Submission Correspondent
Mr. Boyle Wang
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China
Tel: +86-21-50313932
Email: Info@truthful.com.cn
2.0 Device information
Trade name: Heager Medical Laser Family
Common name: Powered Laser Surgical Instrument
Regulation name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Model(s): Sabrina/Adolf.
3.0 Classification
Production code: GEX
Regulation number: 21 CFR 878.4810
Classification: Class II
Panel: General & Plastic Surgery
4.0 Predicate device information
Page 6
Laser type: GaAlAs diode laser
Predicate device
510(k) Number: K212734
Product Name: Diode laser therapy device
Manufacturer: Triangel Rsd Limited
Reference device 1:
510(k) Number: K240179
Product Name: Medical Diode Laser (Model: L2)
Manufacturer: Wuhan Pioon Technology Co., Ltd.
Reference device 2:
510(k) Number: K082721
Product Name: LaserPro 810, LaserPro 980
Manufacturer: PhotoMedex, Inc.
5.0 Indication for Use Statement
The Heager Medical Laser Family is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
6.0 Device description
The Heager Medical Laser Family generates a 980nm wavelength laser to act on a target tissue to achieve hemostasis, ablation, and coagulation of the target tissue. The Heager Medical Laser Family generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Heager Medical Laser Family has following characteristics:
- Dual wavelengths
- Temperature monitoring system
7.0 Non-Clinical Test Conclusion
Table 1 - Product Technical Specification
Page 7
| Device model | Sabrina/Adolf |
|---|---|
| Wavelength | 980nm±20nm, 1470nm±20nm |
| Laser output power | 980±20nm cw 20W1470nm±20nm cw 15W |
| Security level | Class IV type B |
| Laser output mode | Continuous, Pulse, Single. |
| Pulse width | 0.1s-10s (stepping 0.1s) |
| Cooling | Air Cooling |
| Size | 34.5×26.5×27.5cm |
| Net weight | 7.1KG |
| Fuse | F15AL250V |
| Aiming beam | Diode laser of 650nm, power Max. 10mW, adjustable brightness. |
| Beam divergence | 314 mrad to 443 mrad |
| Application systems | Fiber core diameter: 600μm NA>0.22With SMA905 connectorBefore use must be steriled |
| Transmission system | Contact: fibers of 600μm with SMA905 connector;Non-contact: fibers and tips |
| Operation interface | Color LCD touch screen |
| Power supply | 100-220VAC, 50/60Hz,170VA |
| Waterproof level | IPX1 |
| Footswitch Waterproof level | IPX8 |
| Transportation & Storage environmental conditions | Temperature:-20°C~70°C, Relative humidity: 10% |
| Application environmental conditions | Temperature:10°C~33°C, Relative humidity: 10% |
The Heager Medical Laser Family passed the following IEC test requirements:
-
IEC 60601-1: Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
-
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances –Requirements and tests.
-
IEC 60601-2-22 Edition 4.0 2019-11 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic laser equipment.
-
IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]
-
IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral
8.0 Clinical Test Conclusion
No clinical study implemented for the Diode laser therapy device.
9.0 Technological Characteristic Comparison Table
Page 8
Table 2 - General Comparison
| Item | Proposed device | Predicated device | Reference device 1 | Reference device 2 | Remark |
|---|---|---|---|---|---|
| Product Code | GEX | GEX | GEX | GEX | Identical |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Class | II | II | II | II | Identical |
| Product name | Heager Medical Laser Family | Diode laser therapy device | Medical Diode Laser | LaserPro 810, LaserPro 980 | - |
| 510(k) No. | K250261 | K212734 | K240179 | K082721 | - |
| Models | Sabrina/Adolf | ST-AR | L2 | - | - |
| Indications for Use | The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, | The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, | The Medical Diode Laser (Model: L2) is indicated for: -Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue -Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux | The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), | Same |
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| Item | Proposed device | Predicated device | Reference device 1 | Reference device 2 | Remark |
|---|---|---|---|---|---|
| Indications for Use (continued) | gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. | gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. | neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: orthopedics. | Same | |
| Patient Population | Adult | Adult | Adult | Adult | Same |
Table 3 - Performance Comparison
| Item | Proposed Device | Predicate Device | Reference device 1 | Reference device 2 | Remark |
|---|---|---|---|---|---|
| Heager Medical Laser Family | Diode laser therapy device | Medical Diode Laser | LaserPro 810, LaserPro 980 | ||
| N/A | K212734 | K240179 | K082721 | ||
| Wavelength | 980nm±20nm, 1470nm±20nm | 980nm±5nm, 1470nm±10nm | 1470 nm | 980 nm | * Gap 1 |
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| Item | Proposed Device | Predicate Device | Reference device 1 | Reference device 2 | Remark |
|---|---|---|---|---|---|
| Output Power max. | 20W/980nm±20nm, 15W/1470nm±20nm | 16W/980nm±20%, 4.5W/1470nm±20% | Up to 20W | 1-25W/980nm | * Gap 2 |
| Aiming beam | Diode laser of 650nm, power Max. 10mW, adjustable brightness. | 650 nm, red 0.5 mW, user controlled intensity | Undisclosed data | 635-650nm, adjustable intensity | * Gap 3 |
| Treatment mode | Continuous or Pulsed | Continuous, Pulsed, or Single | Continuous or Pulsed | Continuous or Pulsed | Same |
| Power supply | 100-220VAC, 50/60Hz,170VA | AC110V±11V, 60HZ | 110/220 V | 100-240 VAC, 540VA max, 50/60Hz | * Gap 4 |
| Interval | 980nm 1% ~ 100%, 1470nm 2% ~100%, continuously adjustable energy | 980nm 1% ~ 100%, 1470nm 2% ~100%, continuously adjustable energy | 1470nm 2% ~100%, continuously adjustable energy | 980nm 1% ~ 100%, continuously adjustable energy | Same |
| Cooling system | Air cooled | Air cooled | Air cooled | Air cooled | Same |
| Pulse duration range | 0.1 - 10 s | 0.05 ms - 1 s | 10 ms - 10 s | 0.05 s - 10 s | * Gap 5 |
Gap analysis:
Gap 1: Both of the proposed device and predicate device have 980nm and 1470 nm wavelength. The deviations of wavelength are similar, which does not create additional risk to the product use.
Gap 2: The 980nm max power of the proposed device is close to the predicate device, which does not create additional risk to the product use. For 1470nm max power of the proposed device is the same with reference devices, which does not create additional risks.
Gap 3: The aiming beam of the devices are close, which difference does not create additional risks to the product clinical use.
Gap 4: The power supply range of the proposed device is included in the predicate device and reference devices.
Gap 5: The pulse duration range for subject device K250261 is 0.1 - 10 seconds, while the range for predicate device K212734 is 0.05
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milliseconds - 1 second.
For the difference of pulse duration range, we've decided to introduce reference devices, K240179 and K082721.
The pulse duration range for reference device K240179 is 10 ms - 10 s @1470nm.
The pulse duration range for reference device K082721 is 0.05 s - 10 s @980nm.
Both of the reference devices can comprehensively cover the pulse duration range for subject device K250261.
Therefore, this difference will not affect the safety and effectiveness.
Table 4 - Safety Comparison
| Item | Proposed Device | Predicate Device | Reference device 1 | Reference device 2 | Remark |
|---|---|---|---|---|---|
| Heager Medical Laser Family | Diode laser therapy device | Medical Diode Laser | LaserPro 810, LaserPro 980 | ||
| Pending | K212734 | K240179 | K082721 | ||
| Materials contacting user | N/AEven though Fiber is not a component of "Sabrina/Adolf", a suitable fiber is necessary to be connected with "Sabrina/Adolf" to transfer laser energy to the patient. The suitable fiber must meet the following requirements.• 510(k) clearance• Fiber core diameter | Fiber | Fiber | Fiber | / |
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| Item | Proposed Device | Predicate Device | Reference device 1 | Reference device 2 | Remark |
|---|---|---|---|---|---|
| Materials contacting user (continued) | 600μm• NA =0.2• With SMA905 connector• Meet the requirements of ISO 10993 series standards• Single used• Sterile | ||||
| Electric safety | Comply with IEC 60601-1:2005+A1:2012+A2:2020, IEC 60825-1:2014, IEC 60601-2-22:2019 | Comply with IEC 60601-1:2005+A1:2012, IEC 60825-1:2014, IEC 60601-2-22:2007+A1:2012 | Comply with IEC 60601-1:2005+AMD1:2012+AMD2:2020 IEC 60825-1:2014 • IEC 60601-2-22:2019 | Comply with IEC 60601-1, IEC 60825-1, IEC 60601-2-22 | Same |
| EMC | Comply with IEC 60601-1-2:2014+A1:2021 | Comply with IEC 60601-1-2:2014 | IEC 60601-1-2:2014+A1:2020 | Comply with IEC 60601-1-2 | Same |
10.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Heager Medical Laser Family device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K212734.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.