MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)

K091323 · Intermedic Arfran, SA · GEX · Jun 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091323
• Device Name: MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
• Applicant: Intermedic Arfran, SA
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology). Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal. General Surgery, Ophthalmology, Orthopodics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

Device Story

The MULTIDIODE SST 180 is a 980nm diode laser system designed for soft tissue surgery. The system consists of a laser console with a fiber port, RF ID bracket, operating software, a detachable footswitch, and various delivery accessories (fiber optics, handpieces, scanners). The device is operated by physicians in clinical or surgical settings. The laser energy is delivered via fiber optic accessories to the target tissue to perform vaporization, incision, ablation, or coagulation. The physician controls the laser output via the footswitch and console interface. By providing precise thermal energy, the device enables controlled tissue interaction, facilitating surgical procedures across numerous medical specialties, including urology, dermatology, and general surgery. The system's output allows for effective hemostasis and tissue management, potentially reducing operative time and improving patient outcomes in minimally invasive and open surgical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

980nm diode laser system; includes laser console, fiber port, RF ID bracket, detachable footswitch, and delivery accessories (fiber optics, handpieces, scanners). Operates via software-controlled laser emission. Intended for soft tissue surgical applications.

Indications for Use

Indicated for soft tissue surgical applications (vaporization, incision, ablation, cutting, hemostasis, coagulation) across multiple specialties including Urology, Thoracic, Plastic, Dermatology, General, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal, Gynecology, Pulmonary, Neurosurgery, Gastroenterology, ENT, Radiology, Oral/Dental, and Vascular surgery. Includes aesthetic procedures like vascular lesion treatment and hair removal (skin types I-V). Prescription use only.

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

• INTERmedic Diode Laser Family (K053540)
• Biolitec 180W Ceralas D 980nm Diode Laser (Model D180) (K083682)

Submission Summary (Full Text)

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KO91323

## Appendix G - 510(k) Summary for the Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180)

#### I. General Information

Submitter:

INTERmedic Arfran, S.A. Avda. Josep Tarradellas, 91 08029 Barcelona SPAIN

Contact Person:

Francesc Sota Technical Director, INTERmedic Arfran, S.A.

Summary Preparation Date: June 2, 2009

# II.

- Device Names:
Names

Primary Classification Names:

Laser Powered Surgical Instruments (and accessories)

Modified INTERmedic Diode Laser 980nm System

#### III. Predicate Devices

- INTERmedic Arfran, S.A. INTERmedic Diode Lascr Diode Family (K053540) .
(MULTIDIODE SST 180)

- Biolitec. Inc. 180W Ceralas D 980nm Diode Laser (Model D180) (K083682) .
#### IV. Product Description

The modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 180), and the delivery accessories that are used with it, is comprised of the following main components:

- . Laser console with fiber port and RF ID bracket
- A Operating software
- 바 Detachable footswitch
- Delivery device accessories (fiber optic, handpieces and scanner)

#### V. Indications for Use

The modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology). Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal. General Surgery, Ophthalmology, Orthopodics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

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The Indications for Use of the modificd INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) are provided in Appendix D.

#### VI. Rationale for Substantial Equivalence

The modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate INTERmedic Diode Laser Family (K053540) and shares similar functional capabilities as the predicate Biolitec 180W Ceralas D 980nm Diode Laser (Model D180) (K083682).

#### VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is substantially cquivalent to the predicate INTERmedic Diode Laser Family (K053540) and the predicate Biolitec 180W Ceralas D 980nm Diode Laser (Model D180) (K083682):

### VIII. Conclusion

The modified INTERmedic Diode Lascr 980nm System (MULTIDIODE SST 180) was found to be substantially equivalent to the predicate devices.

The modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features 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 text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

INTERmedic Afran S.A. % A.L. Voss Associates Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566

JUN - 4 2009

Re: K091323

Trade/Device Name: The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180)

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: May 1, 2009 Received: May 5, 2009

Dear Ms. Worden:

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 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); medical device reporting of medical

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## Page 2 - Ms. Anne Worden

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 it's Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)

### Indications for Use:

The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovasoular coagulation, Oral Surgery and Dental procedures.

Examples include:

Laser 980 nm

Urology:

- · Lesions of external genitalia
- · Circumcision
- · Condyloma
- · Bladder tumors
- · Bladder neck incisions
- · Vaporization of the prostate.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

** 6 pages total ***

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Ko9/323

Special 510 (k) Premarket Notification for: Appendix D: FDA Indications for Use - Page D-2 Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 200)

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The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)

Indications for Use: Continued

## Laser 980 nm

General Surgery:

· Rectal and anal hemorrhoidectomy

· Mastectomy

· Dermabrasion

· Appendectomy (open and laparoscopic)

· Bowel resection (open and laparoscopic)

· Colectomy

· Liver resection

· Resections of organs

· Thyriodectomy

• Adhesiolysis

· Hepatobiliary tumors

· Throacotomy

· Cholecystectomy (open and laparoscopic)

· Condyloma

· Breast biopsy

## Neurosurgery:

· Percutaneous Disc Decompression

· Discectomy

· Hemostasis in conjunction with meningiomas

*** 6 pages total ***

Prescription Use く Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091322

Page 2 of 6

Special 510 (k) Premarket Notification for: Appendix D: FDA Indications for Use - Page D-3 Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 200)

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The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)

## Indications for Use: Continued

## Laser 980 nm

Gynecology:

- · Cervical conization
- · Myomectomy
- · Endometrial ablation
- · Ovarian cystectomy
- · Appendectomy

## Ophthalmology:

- · Dacryocystorhinostomy transcanalicular
• Open DCR

- · Tumor excision
- · Blepharoplasty

### Orthopedics:

- Dissect and coagulate
### Gastroenterology:

- · Hemostasis of colonoscopy
- · Hemostasis of esophageal varicies
- · Excision of polyps

### Arthroscopy:

- · Chondromalacia
- · Synovectomy
- · Menisectomy

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

*** 6 pages total ***

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number 1609/323

Page 3 of

Special 510 (k) Premarket Notification for: Appendix D: FDA Indications for Use - Page D-4 Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 200)

135

б

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The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)

Indications for Use: Continued

## Laser 980 nm

Thoracic Surgery:

- · Thoracotomy
- · Pulmonary resection
- · Hemostasis
- · Pericardiectomy
- · Adhesiolysis
- · Coagulation of blebs and bullae

### Pulmonology:

- · Endoscopic pulmonary applications
- · Tracheal bronchial lesions
- · Benign and malignant pulmonary obstruction

## Otolaryngology ENT:

- · Removal of benign lesions from the ear, nose and throat
- · Excision of carcinoma of the larynx
- · Incision and excision of carcinoma in situ
- · Neck dissection
- · Laryngeal papillomectomy
- · Removal of vocal cord/fold nodules, polyps and cysts

*** 6 pages total ***

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------------------------|---------|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | 2091323 |

Page 4 of 6

Special 510 (k) Premarket Notification for: Appendix D: FDA Indications for Use - Page D-5 Modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 200)

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The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)

Indications for Use: Continued

## Laser 980 nm

### Dental Applications:

- · Frenectomy
- · Frenotomy
- · Biopsy
- · Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening

## Pulmonary Surgery:

- · Endoscopic pulmonary applications
- · Tracheal bronchial lesions
- · Benign and malignant pulmonary or stricture

## Cardiac Surgery:

- · Coagulation and hemostasis of cardiac tissue
### Dermatology/ Aesthetics:

- · Photocoagulation of vascular & dermatological lesions of the face and extremities
- · Photocoagulation of telangiectasis, veinulectasisas of the legs and face
- · Treatment of reticular veins and branch varicosities
- · Pyogenic granuloma, lymphangioma and lymphagiomatosis disease, angiofibromas
- · Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venus lakes, Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.

*** 6 pages total ***

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

(Division Sign-Off)

Division of Surgical, Orthopedic,

and Restorative Devices

| 510(k) Number | 109/323 |
|---------------|---------|
|---------------|---------|

Page 5 of 6

Special 510 (k) Premarket Notification for: Appendix D. FDA Indications for Use - Page D-6 Modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 200)

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The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)

Indications for Use: Continued

Laser 980 nm

Dermatology/ Aesthetics: Continued

- · Dermatological surgery: Chondyloma acuminate, warts, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcoma. Warty leucoplasy and ulcers debridement.
- · Seborrheic keratoses
- Mixoid cyst
- · Papillary varix
- · Acne treatment
- · Hair removal of unwanted hair from skin types 1-V

Plastic Surgery:

- · Cut, coagulation & vaporization
- · Resurfacing
- · Blepharoplasty

Vascular Surgery:

· Endoluminal or endovenous laser surgery for saphenous incompetent veins

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

*** 6 pages total ***

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------------------------|---------|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | C05/323 |

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