180W CERELAS D 980NM DIODE LASER, MODEL D180

K083682 · Biolitec, Inc. · GEX · Jan 9, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083682
• Device Name: 180W CERELAS D 980NM DIODE LASER, MODEL D180
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 180W Ceralas D 980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

Device Story

180W Ceralas D 980nm Diode Laser delivers laser light to soft tissue via contact or non-contact modes, including endoscopic delivery. Device used in clinical settings (OR, clinic) by physicians for incision, excision, vaporization, ablation, hemostasis, or coagulation. Output is laser energy; clinical effect is thermal tissue interaction. Used for diverse procedures ranging from ENT, arthroscopy, and GI to endovenous occlusion of greater saphenous vein. Physician controls laser parameters to achieve desired surgical outcome; provides precise tissue management; benefits include reduced bleeding and controlled tissue removal.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance data demonstrating equivalence to the predicate device.

Technological Characteristics

980nm diode laser system; 180W maximum power output. Operates in contact and non-contact modes. Compatible with endoscopic delivery. Similar design and principle of operation to the 150W predicate device.

Indications for Use

Indicated for soft tissue surgical procedures (incision, excision, vaporization, ablation, hemostasis, coagulation) in patients requiring otolaryngology, arthroscopy, gastroenterology, general/plastic/podiatric surgery, urology, gynecology, neurosurgery, pulmonary/cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein for superficial vein reflux.

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

• Biolitec's 150W Ceralas D 980nm Diode Laser (K072106)

Submission Summary (Full Text)

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### 510(k) SUMMARY

K083682

## Biolitec Inc.'s 180W Ceralas Diode 980nm Laser System (Model D180)

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

> Hogan & Hartson 555 13th Street NW Washington DC 20004

Phone: [phone] Facsimile: [phone]

Jonathan S. Kahan Contact Person:

Date Prepared: December 11, 2008

### Name of Device and Name/Address of Sponsor

180W Ceralas D 980nm Diode Laser (Model D180)

Biolitec, Inc. 515 Shaker Road East Longmeadow, MA .01028

### Common or Usual Name

Diode Laser

## Classification Name

Laser, Surgical Diode Laser System

#### Predicate Devices

Biolitec's 150W Ceralas D 980nm Diode Laser (K072106)

## Intended Use / Indications for Use

The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 180W Ceralas E980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system),

JAN - 9 2009

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pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

The device is specifically indicated for use as follows:

## Ear, Nose and Throat and Oral Surgery (Otolaryngology)

Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

- Removal of benign lesions from the ear, nose and throat
- Excision and vaporization of vocal cord nodules and polyps
- Incision and excision of carcinoma in situ
- Ablation and vaporization of hyperkeratosis
- Excision of carcinoma of the larynx
- Laryngeal papillomectomy
- Excision and vaporization of herpes simplex I and II
- Neck dissection

## Arthroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

- Menisectomy .
- Synovectorny .
- Chondromalacia .

### Gastroenterology

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

- Hemostasis of upper and lower GI bleeding
- Excision and vaporization of colorectal carcinoma
- Excision of polyps

## General Surgery, Dermatology, Plastic Surgery and Podiatry

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

- . Matrixectomy
- Excision of neuromas .
- Excision of periungual and subungual warts
- Excision of plantar warts .
- Excision of keloids ●
- Liver resection .
- Excision of cutaneous lesions ●
- Hemorrhoidectomy .
- Appendectomy
- Debridement of decubitus ulcers

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- Hepatobiliary tumors
Mastectomy

Dermabrasion

- Vaporization and hemostasis of capillary hemangioma
- Excision, vaporization and hemostasis of abdominal tumors
- Excision, vaporization and hemostasis of rectal pathology
- Pilonidal cystectomy
- Herniorapphy
- Adhesiolysis
- Parathyroidectomy
- Laparoscopic cholecystectomy
- Thyroidectomy
- Resection of organs
- Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities

### Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:

- Vaporization of urethral tumors .
- Release of urethral stricture
- Removal of bladder neck obstruction
- Excision and vaporization of condyloma
- Lesions of external genitalia
- Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

## Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

- Endometrial ablation .
- Excision or vaporization of condylomata acuminate
- Vaporization of cervical intraepithelial neoplasia
- Cervical conization
- Menorrhagia

## Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

### Cardiac Surgerv

Hemostasis and coagulation of soft tissue, including cardiac tissue.

## Pulmonary Surgery

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Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

- . Tracheobronchial malignancy or stricture
- Benign and malignant pulmonary obstruction .
- Endoscopic pulmonary applications

### Dental Applications

Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

## Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

## Technological Characteristics

The 180W Ceralas D 980 has the same technological characteristics as the cleared 150W Ceralas D 980.

## Substantial Equivalence

The 180W Ceralas D 980 is as safe and effective as Biolitec's 150W Ceralas D 980mm Diode Laser (K072106). The Ceralas D 180 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas D 180 and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Ceralas D 180 is as safe and effective as the predicate devices. Thus, the Ceralas D 180 is substantially equivalent to the predicate devices.

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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 image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolitec, Inc. % Hogan & Hartson, LLP Mr. Jonathan S. Kahan 555 Thirteenth Street, Northwest Washington, District of Columbia 20004-1109

Re: K083682

Trade/Device Name: 180W Ceralas D 980nm Diode Laser (Model D180) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II

JAN - 9 2009

Product Code: GEX Dated: December 11, 2008 Received: December 11, 2008

Dear Mr. Kahan:

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 - Mr. George Cho

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 vours.

Mark M. Mulhausen

Mark N. Melkerson 1 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 Statement

## Indications for Use Statement

510(k) Number (if known):

K083682

Device Name: 180W Ceralas D 980nm Diode Laser (Model D180)

Indications for Use:

The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 180W Ceralas D 980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy. gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

The device is specifically indicated for use as follows:

## Ear, Nose and Throat and Oral Surgery (Otolaryngology)

Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear. nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

- Removal of benign lesions from the ear, nose and throat
- Excision and vaporization of vocal cord nodules and polyps
- Incision and excision of carcinoma in situ
- Ablation and vaporization of hyperkeratosis
- Excision of carcinoma of the larynx
- Laryngeal papillomectomy
- Excision and vaporization of herpes simplex I and II
- Neck dissection

### Arthroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation arthroscopic surgery. Examples include:

- Menisectomy
- Synovectomy
- Chondromalacia

(Division Sign-Off)-Division of General, Restorative, and Neurological Devices

## Gastroenterology

510(k) Number

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

{7}------------------------------------------------

- Hemostasis of upper and lower GI bleeding
- Excision and vaporization of colorectal carcinoma
- Excision of polyps

# General Surgery, Dermatology, Plastic Surgery and Podiatry

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

- Matrixectomy
- Excision of neuromas
- Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids
- Liver resection
- Excision of cutaneous lesions
- Hemorrhoidectomy

Appendectomy

- Debridement of decubitus ulcers
- Hepatobiliary tumors
- Mastectomy -
- Dermabrasion
- Vaporization and hemostasis of capillary hemangioma
- Excision, vaporization and hemostasis of abdominal tumors
- Excision, vaporization and hemostasis of rectal pathology
- Pilonidal cystectomy
- Herniorapphy
- Adhesiolysis
- Parathyroidectomy
- Laparoscopic cholecystectomy
- Thyroidectomy
- Resection of organs
- Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the
- n patients with superficial vein reflux.

thigh

- Treatment of reticular veins and branch varicosities
### Urology

Excision, vaporization, incision, coagulation, ablation and hemostas of of wologic Examples include: On

- Vaporization of urethral tumors
(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number

K0f368>

{8}------------------------------------------------

- Release of urethral stricture
- Removal of bladder neck obstruction
- Excision and vaporization of condyloma
- Lesions of external genitalia
- Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

## Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

- Endometrial ablation
- Excision or vaporization of condylomata acuminate
- Vaporization of cervical intraepithelial neoplasia
- Cervical conization
- Menorrhagia

## Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

## Cardiac Surgery

Hemostasis and coagulation of soft tissue, including cardiac tissue.

## Pulmonary Surgery

Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

- Tracheobronchial malignancy or stricture
- Benign and malignant pulmonary obstruction
- Endoscopic pulmonary applications

## Dental Applications

Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown. lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

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Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use with the ELVeS Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

#### Prescription Use X (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mellman

(Division Sign-Off) (Division Sign of General, Restorative, and Neurological Devices

Page of

**510(k) Number** K083682

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