FOX 1-980, FOX Q-1064, FOX-Q-810

K073322 · A.R.C Laser GmbH · GEX · Feb 22, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073322
• Device Name: FOX 1-980, FOX Q-1064, FOX-Q-810
• Applicant: A.R.C Laser GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fox Q-810: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology. Fox Q-980: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery. Fox Q-1064: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Device Story

Fox Q-810, Q-980, and Q-1064 are diode lasers emitting energy at 810nm, 980nm, and 1064nm wavelengths respectively. Devices deliver laser energy to soft tissue via optical fibers for surgical applications; functions include ablation, vaporization, excision, incision, hemostasis, and coagulation. Systems are intended for use by trained clinicians in clinical settings. Output is controlled by the operator to achieve desired tissue effects; clinical benefit derived from precise surgical interaction with soft tissue. Devices are substantially equivalent to existing diode laser systems.

Clinical Evidence

Bench testing only. No clinical data presented. Compliance with international safety and performance standards (IEC 60601 series and 21 CFR 1040) provided as evidence of safety and effectiveness.

Technological Characteristics

Diode laser system; wavelengths 810nm, 980nm, 1064nm. Energy delivery via optical fibers. Complies with IEC 60601-1:1998, IEC 60601-2-22:1995, IEC 60825-1:1993, and 21 CFR 1040.10/1040.11.

Indications for Use

Indicated for patients requiring soft tissue surgical procedures including ablation, vaporization, excision, incision, hemostasis, or coagulation across various medical specialties (dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, thoracic surgery).

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

• Fox Q-810 (K062619)
• Ceralas 980 (K072106)
• Laserscope 1064 (K990903)

Submission Summary (Full Text)

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## K073322

.

# 510(k) SUMMARY – Fox Q-810, Q-980 and Q-1064 Laser

| Applicant Name: | A.R.C. Laser GmbH<br>Bessemerstr. 14, D-90411 Nurnberg, Germany |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Reinhardt Thyzel, President |
| Date Prepared: | February 8, 2008 |
| Device Trade Name: | Fox Q-810, Q-980 and Q-1064 Lasers |
| Device Common Name: | Diode Laser |
| Classification Name: | Laser Surgical Instrument |
| Predicate Devices: | Fox Q-810 (K062619), Ceralas 980 (K072106) and<br>Laserscope 1064 (K990903) |
| Device Description: | Fox Q-810, Q-980 and Q-1064 are standard diode<br>medical lasers with 810, 980nm and 1064nm<br>wavelength, respectively |
| Intended Use: | Fox Q-810:<br>indicated for surgical applications requiring the ablation,<br>vaporization, excision, incision, hemostasis, or<br>coagulation of soft tissues in medical specialties<br>including dermatology, dentistry, gastroenterology,<br>general surgery, neurosurgery, otolaryngology,<br>ophthalmology, and pulmonology. |
| | Fox Q-980:<br>indicated for surgical applications requiring the ablation,<br>vaporization, excision, incision, hemostasis, or<br>coagulation of soft tissues in medical specialties<br>including dermatology, dentistry, gastroenterology,<br>general surgery, genitourinary, gynecology,<br>neurosurgery, otolaryngology, orthopedics, |
| Device Technological<br>Characteristics and<br>Comparison to Predicate<br>Device(s): | The Fox Q-980 uses diodes to generate energy in the<br>980 nm range. (Commercially available) Fibers deliver<br>energy to the tissue. The Fox Q-1064 Laser is the same<br>system, but generates energy in the 1064 nm range.<br>The new Fox Q-810 is also the same, producing energy<br>in the 810 nm range. |
| | Predicates: The Fox Q-810 Laser (cleared under<br>K062619) is the same system, but generates energy in<br>the 810 nm range (at a lower output than the new 810<br>nm device). The Ceralas 980 is also a diode laser<br>producing energy in the 980 nm range, and the<br>Laserscope system produces energy in the 1064 nm<br>range. |
| Performance Standards: | The Fox Q-810, Q-980 and Q-1064 Lasers comply with<br>the performance requirements of 21CFR 1040.10 and<br>1040.11, with permissible deviations defined in Laser<br>Notice 50, dated July 26, 2001. The diode lasers also<br>comply with IEC 60601-1:1998 including amendment 1,<br>IEC 60601-2-22:1995, and IEC 60825-1:1993 including<br>amendments 1 and 2. |
| Conclusion: | The Fox 810, 980 and 1064 Lasers are substantially<br>equivalent to the predicate devices. They have similar<br>intended uses and comply with the same safety and<br>performance standards. |

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ophthalmology, pulmonology, and thoracic surgery.

Fox Q-1064:

indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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FEB 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A.R.C. Laser GmbH % PPD Medical Device Ms. Kirsten H. Paulson 3202 Tower Oaks Blvd. Rockville, MD 20852

Re: K073322 Trade/Device Name: Fox 1-980, Fox Q-1064, Fox Q-810 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 21, 2007 Received: November 26, 2007

Dear Ms. Paulson:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kirsten H. Paulson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millican

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K073322

Device Name: Fox Q-810, Q-980 and Q-1064 Diode Laser Indications for Use:

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#### Fox Q-810:

indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology , general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology .

### Fox Q-980:

indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

#### Fox Q-1064:

indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

| Prescription Use _X_ | AND/OR | Over-The-Counter Use _ |
|-----------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)