Wolf445nm

K192272 · A.R.C Laser GmbH · GEX · Mar 17, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192272
• Device Name: Wolf445nm
• Applicant: A.R.C Laser GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wolf 445nm is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Device Story

Wolf 445nm is a compact diode laser system used for soft tissue surgery; operates via laser diode emitting 445nm wavelength; includes green 532nm aiming beam. Physician operates device via high-resolution color touchscreen; laser energy delivered through optical fibers (300, 400, 600 µm) with or without handpieces. Device performs incision, excision, vaporization, ablation, hemostasis, and coagulation. Air-cooled system; powered by 100-240V AC. Output affects tissue through thermal interaction; provides clinical benefit by enabling precise soft tissue management in general, plastic, and dermatological surgery.

Clinical Evidence

No clinical data. Bench testing only. Comparison of 445nm vs 532nm laser devices evaluated cut depth and thermal damage zones via histological samples to demonstrate equivalent tissue interaction performance. Electrical safety, EMC, and software verification/validation testing performed.

Technological Characteristics

Diode laser system; 445nm wavelength; 0.5W-10W power; air-cooled; touchscreen interface. Dimensions: 10.06cm x 20.3cm x 23.9cm; weight 2.8kg. Connectivity: standalone. Standards: IEC 60601-1, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-6, IEC 62366, IEC 60601-1-2.

Indications for Use

Indicated for incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue in patients requiring surgical intervention.

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

• Aura Laser System (K951034)

Reference Devices

• SiroLaser Blue (K180044)

Submission Summary (Full Text)

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March 17, 2020

A.R.C. Laser GmbH Angela Thyzel General Manager Bessemer St. 14 Nurnberg, 90411 De

Re: K192272 Trade/Device Name: Wolf 445nm 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: February 3, 2020 Received: February 10, 2020

Dear Angela Thyzel:

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 (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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Jessica Mavadia-Shukla, Ph.D. Acting 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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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192272

Device Name Wolf 445nm

Indications for Use (Describe)

The Wolf 445nm is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.

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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Image /page/3/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters. Below that, the word "LASER" is in a white box. Underneath the box, the phrase "enlighten your surgery." is written in a cursive font.

## 510(k) Summary - K192272

| Submitter: | A.R.C. Laser GmbH<br>Bessemer St. 14<br>90411, Nurnberg<br>Germany |
|---------------------------------------------|-----------------------------------------------------------------------------------------------|
| Contact person :<br>Phone<br>Fax<br>E-Mail: | Angela Thyzel, General Manager<br>0911-21779-0<br>0911-21779-99<br>[e-mail] |
| Date<br>Prepared: | March 6, 2020 |
| Device Trade<br>Name: | Wolf 445nm |
| Common<br>Name: | Diode Laser System |
| Classification<br>Name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology |
| Device product<br>code: | GEX |
| Device<br>Classification | 21 CFR 878.4810 |
| Predicate<br>Devices: | Aura Laser System, K951034, Primary Predicate<br>SiroLaser Blue, K180044, Reference Predicate |

Device Description:

The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm.

The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.

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Image /page/4/Picture/1 description: The image shows the logo for A.R.C. Laser. The logo is in a blue box with the text "A.R.C." in large, bold, white letters. Below that is the word "LASER" in smaller, white letters. Underneath the word laser is the company's slogan, "enlighten your surgery" in a cursive font.

# 510(k) Summary – K192272

Indications for Use: The Wolf 445nm is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

# Comparison of Technological Characteristics with the Predicate Devices

The primary predicate device is the Aura laser system (K951034), a KTP laser with a wavelength of 532nm with same intended use as the subject device.

The SiroLaser Blue, K180044, is a reference device, with the same intended use although is used for dental applications, shares the same wavelength, the same product code GEX, same device class and same classification name and number.

| Specification | Subject Device<br>Wolf 445nm | Primary Predicate Device<br>Aura Laser System | Reference Predicate<br>Device SIROLaserBlue |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K192272 | K951034 | K180044 |
| Regulation # | 878.4810 | 878.4810 | 878.4810 |
| Class Code | GEX | GEX | GEX & ILY |
| Class | II | II | II |
| Indications for<br>Use | The Wolf 445nm is intended for use<br>in incision/excision, vaporization,<br>ablation, hemostasis and coagulation<br>of soft tissue | Aura XP is intended for use in in<br>incision/excision, vaporization,<br>ablation, hemostasis and<br>coagulation of soft tissue | SIROLaserBlue is intended<br>for intra and extra oral<br>surgery including incision,<br>excision, hemostasis,<br>coagulation & vaporization<br>of soft tissue |
| Use of device | RX only | RX only | RX only |
| Laser type | Diode Laser | Flash Lamp Pulsed KTP Laser | Diode Laser |
| Laser power | 0.5 W to 10 W | 0.5 W to 15 W | 0.2 W - 3.0 W |
| Wavelength | 445 nm | 532 nm | 445 nm, 660 nm, 970 nm |
| Laser Class | 4 | 4 | 4 |
| Operation<br>mode | Pulsed, Continuous Wave (CW) or<br>Single Pulse (SP) | Pulsed, Quasi continuous wave | Continuous wave (CW) or<br>Pulsed |
| Pulse length/<br>duration | < 4 Watt: 1 ms to 45 sec and CW<br>> 4 Watt: 1 ms to 60 ms | 1 to 50 milliseconds in 1 ms<br>increments, then .1 to 1 sec in<br>0.1 increment, then .5 sec<br>increments to continuous | 10 µs to 0.99 sec. |
| Pulse<br>frequency | < 4 Watt: 0.01 Hz to 500 Hz and SP<br>> 4 Watt: 0.02 Hz to 6.6 Hz and SP | 0.5 Hz to 5 Hz | 1 Hz to 10 kHz |
| Aiming beam<br>wavelength | 532 nm | 635 nm | 660 ± 5 nm |
| Aiming beam<br>power | < 5 mW | 5 mW | max. 1 mW |

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Image /page/5/Picture/1 description: The image features the logo of A.R.C. Laser, set against a solid blue background. The acronym "A.R.C." is prominently displayed in large, bold white letters, positioned above the word "LASER," which is enclosed in a white box. Below the boxed word, the tagline "enlighten your surgery." is written in a cursive font, completing the logo's design.

#### Page 2 of 4 510(k) Summary - K192272

| Specification | Subject Device<br>Wolf 445nm | Primary Predicate Device<br>Aura Laser System | Reference Predicate<br>Device<br>SIROLaserBlue |
|-------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Use in<br>combination | Delivery devices<br>optical fibers 300 µm, 400 µm and<br>600 µm with or without hand<br>pieces | Delivery devices - Multiple<br>Aura Fibers and accessories<br>for various applications | Delivery devices, fibers<br>200 µm, 320 µm |
| Cooling | Air | Air | Air |
| Display | Touch screen | Buttons and regulators | Touch screen |
| Main power<br>Supply | 100-240 V~, 47-63 Hz, 1.06-0.45 A | 120 V AC/ 15 AMPS<br>230 V AC/ 10 AMPS | 15 V DC 6.66 A max.<br>100 VA MPU101-106 |
| Dimensions<br>of system | H 10.06 cm (3.9 inches)<br>W 20.3 cm (7.9 inches)<br>L 23.9 cm (9.4 inches) | H 41 cm (16 inches)<br>W 30.5 cm (12 inches)<br>L 58 cm (23 inches) | H 18.2 cm (7.1 inches)<br>W 19.7 cm (7.7 inches)<br>L 18.9 cm (7.4 inches) |
| Weight | 2.8 kg (6.17 pounds) | 27 kg (60 pounds) | 1.3 kg (2.86 pounds) |

#### Comparison of Technological Characteristics with the Predicate Devices (continuation)

### Performance Data

The safety and effectiveness determination of the 445nm subject device compared to the primary predicate with wavelength 532nm is supported by the Electrical Safety, EMC, Software, and non-clinical comparison bench tests provided in the submission.

### Non clinical testing :

A comparison bench test between 445 nm and 532 nm laser devices was conducted with the purpose of demonstrating that the Wolf 445 nm provides as safe & effective performance data as a KTP Laser (532 nm) in terms of tissue interaction processes.

The cut depth (effectiveness) and thermal damage (safety) zones of the 445nm laser device were used for the purpose of comparison.

Following the tests, histological samples were evaluated for areas of visible alteration of depth and width of the incision as well as zones of thermal and mechanical damage created by the tests.

# Electrical Safety and EMC testing:

Electrical safety and EMC testing were conducted on the Wolf 445nm, consisting of Diode laser console and optical fibers.

The Wolf 445nm system has been tested for Electrical Safety according to IEC 60601-1:2005 A1:2012 and /or EN 60601-1:2006/A1:2013, for Laser Safety according to IEC 60825-1: 2014 (edition 3.0), for Safety of laser according to IEC 60825-1:2014 and IEC 60601-2-22:2007/A1:2012, for Usability with IEC 60601-1-6:2010/A1:2013 and IEC 62366:20017, AMD1:2014.

Electromagnetic Compatibility was tested according to IEC 60601-1-2:2014, (edition 4.0).

### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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Image /page/6/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, stacked above the word "LASER", which is also in white. Below "LASER" is the tagline "enlighten your surgery.", written in a smaller, italicized font.

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# 510(k) Summary - K192272

The software is considered as a moderate level of concern and the documentation was provided accordingly.

### Summary

Based on the clinical performance, technological characteristics and performance data as documented in this submission, the Wolf 445nm was found to have a safety and effectiveness profile that is similar to the predicate devices.

# Conclusion

The safety and effectiveness determination between the subject and the predicate devices is supported by the performance data provided in the submission, the electrical and EMC testing, the software verification and validation testing and the non-clinical bench test demonstrating that the Wolf 445nm performs comparably to the predicate device that is currently marketed for the same intended use.

Animal or clinical studies: None