Heager Medical Laser Family (Sabrina/Adolf)

K250261 · Heager GmbH · GEX · Aug 26, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K250261
• Device Name: Heager Medical Laser Family (Sabrina/Adolf)
• Applicant: Heager GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 26, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, 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.

Device Story

Heager Medical Laser Family (Sabrina/Adolf) is a dual-wavelength (980nm/1470nm) GaAlAs diode laser system. Device delivers laser energy to soft tissue via fiber optic delivery systems in contact or non-contact modes. System includes temperature monitoring, color LCD touch screen interface, and air cooling. Operated by clinicians in surgical settings for soft tissue procedures and endovenous treatment. Laser energy interacts with tissue to achieve hemostasis, ablation, or coagulation; 1470nm wavelength specifically targets water molecules for vein treatment. Output parameters (power, pulse duration, mode) are user-controlled via interface. Benefits include precise tissue interaction and minimally invasive surgical capability.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1, IEC 60601-2-22).

Technological Characteristics

GaAlAs diode laser; dual wavelength 980nm/1470nm; air-cooled; Class IV laser; 650nm aiming beam; fiber optic delivery (600μm core, SMA905 connector); color LCD touch screen; IPX1 device/IPX8 footswitch; 100-220VAC power. Complies with IEC 60601-1, 60601-1-2, 60601-2-22, and 60825-1.

Indications for Use

Indicated for soft tissue surgical procedures (incision, excision, vaporization, ablation, hemostasis, coagulation) in ENT, oral surgery, dental, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, and gynecology. Also indicated for laser-assisted lipolysis and treatment of saphenous vein reflux associated with varicose veins.

Regulatory Classification

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.

Predicate Devices

• Diode laser therapy device (K212734)

Reference Devices

• Medical Diode Laser (Model: L2) (K240179)
• LaserPro 810, LaserPro 980 (K082721)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250261 - Boyle Wang
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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
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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 ([e-mail]) or phone [phone] 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

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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)

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510(k) Summary K250261

# 510(k) Summary

# K250261

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

## 1.0 Submitter's information

Name: Heager GmbH

Address: Friedrich-Ebert-Straße 111 - 117, 42781 Haan, Germany

Phone Number: [phone]

Contact: Wolfgang Christiani

Email: [e-mail]

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: [phone]

Email: [e-mail]

## 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

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510(k) Summary K250261

## 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

| Laser type | GaAlAs diode laser |
| --- | --- |

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510(k) Summary K250261

| Device model | Sabrina/Adolf |
| --- | --- |
| Wavelength | 980nm±20nm, 1470nm±20nm |
| Laser output power | 980±20nm cw 20W
1470nm±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>0.22
With SMA905 connector
Before 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%~90%,
Atmospheric pressure: 80KPa~106KPa Without sensible vibration and shock |
| Application environmental conditions | Temperature:10°C~33°C, Relative humidity: 10%~90%,
Atmospheric pressure: 80KPa~106KPa |

The Heager Medical Laser Family passed the following IEC test requirements:

1. IEC 60601-1: Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
2. 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.
3. 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.
4. 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)]
5. 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

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510(k) Summary K250261

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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510(k) Summary K250261

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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510(k) Summary K250261

| 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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510(k) Summary K250261

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/A
Even 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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510(k) Summary K250261

| | 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.