FOTONA NOVALIS ER: YAG LASER SYSTEM

K991632 · Fotona D.D. · GEX · Aug 10, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991632
• Device Name: FOTONA NOVALIS ER: YAG LASER SYSTEM
• Applicant: Fotona D.D.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fotona Novalis Er: Y AG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies. General Surgery : surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated. Genitourinary : lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon. Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Oral/Maxillofacial : benign oral tumors, oral and glossal lesions and gingivectomy. Otorhinolaryngology/Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia. Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy. Podiatry : warts, plantar vernicae, large mosaic verrucae and matrixectorny.

Device Story

Microprocessor-controlled Er:YAG laser system; generates 2940 nm pulsed light. Integrated as an accessory to the Fotona Novalis Ruby laser system; shares touchscreen interface. Comprises optical delivery system (articulated arm, handpiece), electronic power supply, and optical chamber (laser rod/cavity). Operated by clinicians in surgical/clinical settings. Laser energy delivered to soft tissue for incision, excision, ablation, vaporization, and coagulation. Provides precise tissue interaction for various surgical specialties; benefits include controlled tissue removal and hemostasis.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Flashlamp-pumped Er:YAG laser; 2940 nm wavelength. Microprocessor-controlled. Optical delivery via articulated arm and focusing/collimated handpiece. Electronic power supply and interface circuitry. Accessory: Fotona SkinScan. Class II device.

Indications for Use

Indicated for surgical incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue across dermatology, plastic surgery, general surgery, genitourinary, gynecology, oral/maxillofacial, ENT, ophthalmology, and podiatry specialties. Applicable to patients requiring soft tissue management including tumors, lesions, cysts, and various dermatological conditions.

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

• Laserscope Venus Erbium Laser System
• Continuum Biomedical (Con-Bio) CB Erbium/2.94 Er: YAG Laser

Submission Summary (Full Text)

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AUG 10 199

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#### Summary of Safety and Effectiveness Data Appendix E u

# General Information and Description

The Fotona Novalis Er. YAG system ia a microprocessor controlled device which generates lascr light with a wavelongth of 2940 nm when used in conjunction with a host Novelis R system. When combined, the Er. YAG accessory and the host Ruby system constitute the Novalis RE laser system.

The Fotona Er. Y AG system is designed as an accessory for use with the Fotona Novalis R laser system "The Fir Y A ( suh-system is fincrionally integrated to the host laser system. When integrated, the host laser system recognizes the presence of the accessory and permits activation of the 2940 nm pulsed light via the same touchscreen as the host Ruby

The Novalis Er. YAG system is designed with 3 major sub-systems:

d) An optical dclivery system, interfacing the cncrgy from the lascr to the patient via an articulated arm and a focusing or collimated handpiece.

b) An electronic power supply and interfsce circuitry.

c) An optical chamber containing laser rod and laser cavity optics.

Accessories available for use with the Fotona Novalis Er: Y AG:

- Fotona SkinScan Scanning Device .
### Summary of Substantial Equivalence

Fotona believes that its Novalis system is substantially equivalcnt to the Lascrscope Venus Erbium Laser System (EL Laser System) and to the Continuum Biomedical (Con-Bio) CB Erbium/2.94 Er: YAG Laser.

Both lasers are cleared for surgical incision, cutting, ablation, vaportzation, and coagulation of soft tissue All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.

Technologically, the predicate devices have identical characteristics to the Novalis Er: Y AG laser, all three comprising an electronic control module and a flashlamp pumped Er. YAG laser rod generating light at a wavelength of 2.94 um, which is subsequently delivered to the patient via an articulated delivery arm and focusing or collimated handpiece.

The risk and benefits for the Fotona Novalis are comparable to the Laserscope Venus Laser System and Continuum Biomedical (Con-Bio) CB Erbium/2.94 Er: YAG Laser System when used for similar clinical applications.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 10 1999

Ms. Mojca Valjavec, Dipl. Eng. Product Manager Lasers Division Fontona d.d. Stegne 7, 1210 Ljubljana, Slovenia

K991632 Re: K991634 Trade Name: Fontona NovalisR Ruby Laser System Fontona Novalis Er: YAG Laser System Regulatory Class: II Product Code: GEX Dated: May 3, 1999 Received: May 12, 1999

Dear Ms. Valjavec:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above, and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 – Ms. Mojca Valjavec, Dipl. Eng.

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

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification (21 CFR 807.97)." Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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## APPENDIX F

Page I of 1

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

. 201

# FOTONA NOVALIS Er: YAG LASER SYSTEM

Indications For Use:

The Fotona Novalis Er: Y AG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs, and glands

DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies.

General Surgery : surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated

Genitourinary : Jesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon

Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma

Oral/Maxillofacial : benign oral tumors, oral and glossal lesions and gingivectomy

Otorhinolaryngology/Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia

Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy

Podiatry : warts, plantar vernicae, large mosaic verrucae and matrixectorny

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:left;">X</div> |
|------------------------------------------|---------------------------------------|
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OR

| (Division Sign-Off) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K991632 |
| Over-The-Counter Use | |

Premarket Notification for Fotona Novalis Fri VAC. I asar Custom