LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980

K040294 · Photo Medex, Inc. · GEX · May 5, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040294
• Device Name: LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
• Applicant: Photo Medex, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are intended for delivery of laser light in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are generally indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, hemostasis or coagulation of soft tissue in surgical procedures in medical specialties including: dermatology, gastroenterology, general surgery (including specific treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein), genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Device Story

LaserPro 810, 940, and 980 are diode laser systems providing specific wavelengths for soft tissue surgery. System includes laser console, fiber port (SMA-905), display panel with soft-touch keypad, microprocessor control electronics, and detachable footswitch. Operated by physicians in clinical/surgical settings. Device delivers laser energy via fiber delivery systems/accessories in contact or non-contact modes, including through endoscopes, introducers, or catheters. Microprocessor controls laser output parameters. Output allows for precise tissue ablation, vaporization, excision, incision, and coagulation. Clinical benefit includes effective soft tissue management across diverse medical specialties. No new clinical indications compared to predicates.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through adherence to mandatory and voluntary standards and comparison to legally marketed predicate devices.

Technological Characteristics

Diode laser system; wavelengths 810nm, 940nm, or 980nm; SMA-905 fiber connector; microprocessor-controlled; soft-touch keypad interface; detachable footswitch; console/cabinet form factor.

Indications for Use

Indicated for soft tissue ablation, vaporization, excision, incision, hemostasis, and coagulation across multiple surgical specialties including dermatology, gastroenterology, general surgery (including varicose veins), urology, GYN, neurosurgery, ENT, orthopedics, ophthalmology, pulmonology, and 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

• Diomed D15 & D30 Laser Systems (K023543)
• Premier Aurora Laser System (K954316)
• SLT Thermalite 810, 940 & 980 Laser Systems (K952661)

Submission Summary (Full Text)

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MAY - 5 2004

510(k) SUMMARY

K040294

### PhotoMedex, Inc.

# LaserPro 810, 940 and 980 Systems Dioxide Laser Systems

#### 1. GENERAL

| • | Submitter: | PhotoMedex, Inc. |
|---|------------|----------------------------|
| | | 147 Keystone Drive |
| | | Montgomeryville, PA, 18936 |

- Bob Rose Contact Person: .
- February 2, 2004 Date Prepared: .

#### DEVICE NAME 2.

- · Classification name: Lascr surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810)
- Common or usual name: Diode laser .
- Trade or proprietary name: LascrPro Diode Surgical Laser System .

#### 3. PREDICATE DEVICES

Diode Surgical Laser Systems

- Diomed D15 & D30 Laser Systems (K023543) .
- Premier Aurora Laser System (K954316) .
- SI.T Thermalite 810, 940 & 980 Laser Systems (K952661) .

### 4. DEVICE DESCRIPTION

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810nm, 940nm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary . The system is comprised of the following main components:

- A laser console/cabinet with fiber port to accept SMA-905 connectors. .
- Display panel with soft-touch keypad control and separate Emergency Off . button.
- Laser system microprocessor control electronics with operating software .
- A detachable covered footswitch. .

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#### 5. INDICATIONS FOR USE

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems (and the fiber delivery systems and accessories that are used with them 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: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, orthopedics, podiatry, pulmonology, and thoracic surgery.

#### 6. SUBSTANTIAL EQUIVALENCE

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems, when used in conjunction with cleared delivery accessories, share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to the predicate devices which includes the Diomed D15 & D30 Laser Systems (K023543), the Premier Aurora Laser System (K954316), and the SLT Thermalite 810, 940 & 980 Laser Systems (K952661).

#### 7. SAFETY AND EFECTIVENESS

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed, tested and manufactured in accordance with both mandatory and voluntary Standards ensuring when used with marketed cleared delivery systems identified to be compatible, they are considered both safe and effective for the medical applications indicated. No new clinical indications are to be provided by the introduction of LaserPro Diode Surgical Lasers as compared to the identified predicates, which have previously demonstrated clinical effectiveness.

#### 8. CONCLUSIONS

Based on the information reviewed and provided within this application, PhotoMedcx believes that the LaserPro 810. 940 and 980 Diode Laser Systems are substantially equivalent to, and are safe and effective as the legally marketed identified predicate devices, the Diomed D15 & D30 Laser Systems (K023543), Premier Aurora Laser System (K954316), and the SLT Thermalite 810, 940 & 980 Laser Systems (K952661), in that they share the same mechanisms for laser energy delivery and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

Mr. Bob Rose Director of Regulatory Affairs PhotoMedex, Inc. 147 Keystone Drive Montgomeryville, Pennsylvania 18936

Re: K040294

Trade/Device Name: LaserPro® 810, 940, and 980 Surgical Diode Laser Systems 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: February 5, 2004 Received: February 6, 2004

Dear Mr. Rose:

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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered prox to may 2011 - 11:45 accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). and Coometter Free) 110) xxx the device, subject to the general controls provisions of the Act. The I ou may, aterer or , mains 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 (sec 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 docs not mean r hat 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 Crici are on your may (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 - Mr. Bob Rose

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in you ve FDA finding of substantial equivalence of your device to a legally premits to the neations 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 n you doch office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provoost

Colia M. Witten, Ph.D., M.D. 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): K040294

Device Name: LaserPro® 810, 940 and 980 Surgical Diode Laser Systems

Intended Use/Indications For Use:

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are intended for delivery of laser light in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are generally indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, hemostasis or coagulation of soft tissue in surgical procedures in medical specialties including: dermatology, gastroenterology, general surgery (including specific treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein), genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Muriam C. Provost

Division of General. Restorative, ver-The-Counter Use Prescription Use

(21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)