MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS

K042211 · Surgical Laser Technologies, Inc. · GEX · Nov 8, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042211
• Device Name: MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
• Applicant: Surgical Laser Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Gastroenterology, Neurosurgery, General Surgery, Genitourinary (Urology), Thoracic Surgery, Gynecology (GYN), Pulmonology, Ophthalmology, Orthopedics, and Otolaryngology (ENT).

Device Story

LaserPro 810, 940, and 980 are diode laser systems providing laser energy at specific wavelengths (810nm, 940nm, 980nm). System consists of a laser console with fiber port, display panel with soft-touch keypad, microprocessor control electronics, and detachable footswitch. Device delivers laser energy via fiber delivery systems to target soft tissue for ablation, vaporization, excision, incision, or coagulation. Modifications include increased maximum output power (20 to 25 Watts) and user-adjustable aiming beam intensity. Used in clinical settings (OR, clinic) by physicians across multiple specialties (e.g., general surgery, ENT, GYN). Output is controlled by the surgeon via footswitch and console interface. Clinical benefit includes precise soft tissue management in various endoscopic and open surgical procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design similarities, identical mechanisms of action, and established clinical effectiveness of the predicate devices.

Technological Characteristics

Diode laser system; wavelengths 810nm, 940nm, 980nm; max output 25W. Components: laser console, fiber port (SMA-905), display panel, soft-touch keypad, microprocessor control, detachable footswitch. Energy source: electrical to laser diode. Connectivity: standalone. Sterilization: not specified (accessories are cleared delivery systems).

Indications for Use

Indicated for soft tissue ablation, vaporization, excision, incision, and coagulation in gastroenterology, neurosurgery, general surgery (including varicose vein treatment), urology, thoracic surgery, gynecology, pulmonology, ophthalmology, orthopedics, and ENT. Applicable to adult and pediatric patients requiring soft tissue 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

• PhotoMedex LaserPro 810, 940 and 980 Diode Laser Systems (K040294)
• 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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NOV - 8 2004

### 510(k) SUMMARY

K042211

# PhotoMedex, Inc.

# LaserPro 810, 940 and 980 Systems Diode Laser Systems

### 1. GENERAL

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

- Bob Rose Contact Person: .
- August 13, 2004 (Revised September 15, 2004) Date Prepared: .

### 2. DEVICE NAME

- · Classification name: Laser 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: LaserPro Diode Surgical Laser System .

### 3. PREDICATE DEVICE (Device to be Modified)

### Diode Surgical Laser Systems

- PhotoMedex LaserPro 810, 940 and 980 Diode Laser Systems (K040294) ◆
# 4. DEVICE DESCRIPTION and DEVICE MODIFICATIONS

The PhotoMedex LaserPro 810, 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810mm, 940mm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary. These devices have been cleared previously via K040294. Differences between the cleared and modified device are limited to:

- * Maximum output power increased from 20 to 25 Watts (Systems are identified by output frequency and maximum power).
- · User adjustable (intensity) aiming beam (the maximum aiming beam optical power does not change from currently cleared device).

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, maision, incision, and coagulation of soft tissue in medical specialties including:

#### Gastroenterology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices, palliation of malignant dysphagia, palliative ablation of obstructive neoplasms, hemostasis of colonoscopy.

#### Neurosurgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord, tumors adjacent to the cortex.

#### General Surgery

Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic appendectomy, cholecystectomy, and bowel resection. Open: mastectorny, reduction mammoplasty, breast biopsy, rectal and anal hemorrhoidectomy, bowel resection, colectorny, cholecystectorny, liver resection, condyloma, thyroidectorny, thoracotomy, and cavemous hemangioma.

### Genitourinary (Urology)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral incision of the prostate (TUIP), bladder tumors, bladder neck incisions, urethral strictures, and exterior sphincterotomy. Laparoscopic lymphadenectomy. Open; condyloma, circumcision, and benign and malignant lesions of external genitalia.

### Thoracic Surgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection, coagulation of blebs and bullae, adhesiolysis, pericardiectomy, mediastinal and thoracic lesions and abnormalities, mediastinal lymph node dissection, and hemostasis, thoracotomy.

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Premarket Notification: LaserPro@ 810. 940 and 980 Diode Laser Systems

### Gynecology (GYN)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic, excision/lysis of adhesions, endometrial lesions, including ablation of endometriosis, laparoscopic assisted hysterectomy (LAVH), laser uterosacral nerve ablation (LUNA), myomectomy, ovarian cystectomy, ovarian drilling, tubal fimbrioplasty, and appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN. Condyloma acuminata, including cervical, genital vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine; fibroids/polyps/adhesions, resection of septum.

### Pulmonology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.

### Opthomology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics, open DCR, endo-nasal DCR, tumor excision (and) biopsy, eyelid reconstruction, and blepharoplast,

#### Orthopedics

The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthoped surgery procedures. Applications include: dissect and coagulate.

### Otolaryngology (ENT)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus; turbinectorny and turbinate reduction/ablation, polypectomy of nose and nasal passages, ethmoidectomy, and meatal antrostomy. Laryngo-tracheal; removal of vocal cord/fold nodules, polyps and cysts, arytenoidectomy, and tracheal stenosis. Oropharyngeal; uvulopalatoplasty (LAUP, laser UPPP), tonsillectomy (including tonsillar cryptolysis, neoplasma) tonsil, and hemi glossectomy. Head & Neck; tumor resection on oral, subfacial and neck tissues, parathyroidectomy, and thyroidectomy.

### 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 equivale 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).

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## 7. SAFETY AND EFECTIVENESS

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed, t the I notornounce with both mandatory and voluntary and voluntary Standards ensuring when used with marketed cleared delivery systems identified to be chisating when 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 havel previously demonstrated clinical effectiveness.

### 8. CONCLUSIONS

PhotoMedex believes that the (minor) modifications to the LaserPro 810. 940 and 980 I hotorious believes are substantially equivalent to, and are safe and effective as the Legally marketed identified predicate devices, the LaserPro 810, 940 and 980 Diode Laser Systems (K040294), in that they share identical mechanisms for laser energy delivery and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that suggest movement or flight. The seal is black and white.

NOV - 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert Rose Director of Regulatory Affairs and Quality Assurance PhotoMedex, Inc., 147 Keystone Drive Montgomeryville, Pennsylvania 18936

Re: K042211

Ko42211
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: August 13, 2004 Received: August 16, 2004

Dear Mr. Rose:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications ferenced above and harrsure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to regions of the Medical Device Amendments, or to conimered process to may 20, 2017 11:11 in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmeter Fer (110) inst the device, subject to the general controls provisions of the Act. The r ou may, merelore, manns of the Act include requirements for annual registration, listing of general controls provision 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 rr your device is elabilition (see as courols. 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 thany 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 - Mr. Robert Rose

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you'll finding of substantial equivalence of your device to a legally premarket notification. The PDF interessification 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 If you desire spocently arrive ior your and [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 mionmational 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. Provost

Celia 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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510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

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

Indications For Use:

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems The PhotoMedex Laserro 810, 940 and 960 burgious Drouse in survicel applications requiring the including and accessories used to deliver laser energy, are multation of soft tissue in medical specialites including: ablation, vaportzation, excision, incision, and coaganator or orders ), genecology (GYN), neurosurgery, gastroenterology, gelleral surgery, gentournial y carges) ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the The PhotoMedex LaserPro 310, 940 and 900 bargetters of the surgery, genitouring surgery performance of specific surgical applications in gasa one organizations of the openitialmology, pulmonology, and thoracic surgery as follows:

### Gastroenterology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include:

- hemostasis of esophageal varices; -
- palliation of malignant dysphagia; -
- palliative ablation of obstructive neoplasms; ー
- hemostasis of colonoscopy. -

*** Page 1 of 6 (Indications For Use Continued on Next Page; 6 pages total) ***

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

X Prescription Use _ (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

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

Indications For Use:

Continued from previous page:

#### Neurosurgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include:

- tumors adjacent to the spinal cord; -
- tumors adjacent to the cortex. -

#### General Surgerv

Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include:

- Laparoscopic ﺗ
- appendectomy; ,
- cholecystectomy; -
- bowel resection. ,
- Open
- i mastectomy;
- reduction mammoplasty; ।
- breast biopsy;
- rectal and anal hemorrhoidectomy; -
- bowel resection; -
- colectomy; -
- cholecystectomy; -
- liver resection; -
- condyloma; -
- thyroidectomy; -
- thoracotomy; -
- cavemous hemangioma. -

*** Page 2 of 6 (Indications For Use Continued on Next Page; 6 pages total) ***

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510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

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

Indications For Use:

Continued from previous page:

### Genitourinary (Urology)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include:

- Transurethral ..
- transurethral incision of the prostate (TUIP); ・
- bladder tumors; -
- bladder neck incisions; -
- urethral strictures; -
- exterior sphincterotomy. -
- Laparoscopic -
- Lymphadenectomy. ।
- Open
- condyloma; ,
- circumcision ।
- benign and malignant lesions of external genitalia. -

### Thoracic Surgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include:

- pulmonary resection; ー
- coagulation of blebs and bullae; -
- adhesiolysis; -
- pericardiectomy .
- mediastinal and thoracic lesions and abnormalities; -
- mediastinal lymph node dissection; –
- hemostasis; «
- thoracotomy. -

*** Page 3 of 6 (Indications For Use Continued on Next Page; 6 pages total) ***

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510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________ K042211_

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

Indications For Use:

Continued from previous page:

### Gynecology (GYN)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include:

- Laparoscopic
- excision/lysis of adhesions; -
- endometrial lesions, including ablation of endometriosis; -
- laparoscopic assisted hysterectomy (LAVH); -
- laser uterosacral nerve ablation (LUNA); -
- myomectomy; -
- ovarian cystectomy; -
- ovarian drilling; -
- tubal fimbrioplasty; -
- appendectomy. -
- Open
- en । vaginal intraepithelial neoplasia VIN, VAIN;
- vagnal intraceptinental nooplaste cervical, genital, vulvar, perineal, and Bowen's disease, -(Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions.
- Intrauterine -
- Fibroids/polyps/adhesions; -
- Resection of septum. -

### Pulmonology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include:

- tracheal bronchial lesions. ।

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510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________ K042211 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Indications For Use:

Continued from previous page:

#### Opthomology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include:

- Oculoplastics
- open DCR; 1
- endo-nasal DCR; -
- tumor excision and biopsy; -
- eyelid reconstruction; -
- blepharoplasty.

#### Orthopedics

The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include:

- Open -
- Dissect and coagulate. -

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510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________ K042211

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

Indications For Use:

Continued from previous page:

### Otolaryngology (ENT)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include:

- Nasal/Sinus
- turbinectomy and turbinate reduction/ablation; -
- polypectomy of nose and nasal passages; -
- ethmoidectomy; -
- meatal antrostomy; -
- Laryngo-tracheal
- removal of vocal cord/fold nodules, polyps and cysts; -
- arytenoidectomy; -
- tracheal stenosis; -
- Oropharyngeal
- uvulopalatoplasty (LAUP, laser UPPP); -
- tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; ・
- hemi glossectomy; -
- Head & Neck
- tumor resection on oral, subfacial and neck tissues; -
- parathyroidectomy; ・
- thyroidectomy. …

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number K042211

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