CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER

K090164 · Biolitec, Inc. · GEX · Jun 26, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090164
• Device Name: CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 26, 2009
• Decision: SESE
• Submission Type: Traditional
• 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 Ceralas Multiwavelength 980/1470 Diode Laser 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 Multiwavelength laser is further indicated for laser assisted lipolysis.

Device Story

Diode laser system delivers 980nm and 1470nm laser energy to soft tissue; used in contact or non-contact modes, including via endoscopes. Operated by physicians in clinical/surgical settings (OR, clinic). Device transforms electrical energy into laser light for surgical applications: incision, excision, vaporization, ablation, hemostasis, coagulation. Output is laser light delivered to target tissue; healthcare provider uses output to perform surgical procedures, potentially reducing bleeding and tissue trauma compared to traditional methods. Used with ELVes Procedure Kit for endovenous occlusion.

Clinical Evidence

Bench testing only; no clinical data presented. Performance testing demonstrated no significant difference compared to cleared predicate devices.

Technological Characteristics

Diode laser system emitting 980nm and 1470nm wavelengths. Operates in contact and non-contact modes. Intended for soft tissue surgical applications. No specific materials, software architecture, or connectivity details provided.

Indications for Use

Indicated for patients requiring soft tissue surgery (incision, excision, vaporization, ablation, hemostasis, coagulation) across various specialties including ENT, arthroscopy, GI, general/plastic/podiatric surgery, urology, gynecology, neurosurgery, pulmonary, cardiothoracic, and dental. Also indicated for endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser-assisted lipolysis.

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

• Cynosure Smart Lipo Multiwavelength Laser (K080121)
• Biolitec Ceralas 980nm Diode Laser (K072106)
• Biolitec Ceralas 1470nm Diode Laser (K073063)

Submission Summary (Full Text)

{0}------------------------------------------------

090164 Page (1) of (5)

# 510(k) SUMMARY

# Biolitec Inc.'s Ceralas Multiwavelength 980/1470nm Diode Laser System

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

Hogan & Hartson 555 13th Street NW Washington DC 20004

JUN 26 2009

[phone] Phone: Facsimile: [phone]

Jonathan S. Kahan Contact Person:

January 21, 2009 Date Prepared:

## Name of Device and Name/Address of Sponsor

Ceralas Multiwavelength 980/1470nm Diode Laser

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

# Common or Usual Name

Diode Laser

## Classification Name

Laser, Surgical Diode Laser System, 21 C.F.R. 878.4810, Product Code GEX

## Predicate Devices

Cynosure Smart Lipo Multiwavelength Laser (K080121) Biolitec Ceralas 980nm Diode Laser (K072106) Biolitec Ceralas 1470nm Diode Laser (K073063)

\ \ \ \ DC - 061213/00001 - 2831829 v2

{1}------------------------------------------------

090164 page (2) of (5)

#### 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 Ceralas Multiwavelength 980/1470nm Diode Laser 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 Multiwavelength laser is further indicated for laser assisted lipolysis.

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

{2}------------------------------------------------

K090164 Page 3 of (5)

# 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 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) .

{3}------------------------------------------------

090164 Page (4) of (5)

## 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.

# 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.

{4}------------------------------------------------

091164 Page (5) of (5)

# Technological Characteristics

The Ceralas Multiwavelength 980/1470 Diode Laser emits laser energy at the 980nm and 1470nm wavelengths in a manner substantially similar to the Ceralas 980 and Ceralas 1470.

## Performance Data

Performance testing of the Ceralas Multiwavelength 980/1470 Diode Laser demonstrates no significant difference as compared to the cleared predicate devices.

## Substantial Equivalence

The Ceralas Multiwavelength 980/1470nm Diode Laser is substantially equivalent to the Cynosure Smart Lipo Multiwavelength Laser, the Biolitec Ceralas 980mm Diode Laser and the Ceralas 1470nm Diode Laser. The Ceralas Multiwavelength 980/1470mm Diode Laser 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 Multiwavelength 980/1470mm Diode Laser and its predicate devices raises no new issues of safety or effectiveness. Thus, the Ceralas Multiwavelength 980/1470nm Diode Laser is substantially equivalent.

{5}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

JUN 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolitec, Inc. % Hogan & Hartson LLP Mr. Jonathan S. Kahan Columbia Square 555 13th Street Northwest Washington, District of Columbia 20004

Re: K090164

Trade/Device Name: Ceralas Multiwavelength 980/147nm Diode Laser 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: June 2, 2009

Dear Mr. Kahan:

Received: June 3, 2009

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 (reporting of medical

{6}------------------------------------------------

# Page 2 - Mr. Jonathan S. Kahan

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/CDRH/CDRHOffices/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 its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark McMillan

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

Enclosure

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

# Indications for Use Statement

| 510(k) Number (if known):_ | KC |
|----------------------------|----|
|----------------------------|----|

Device Name: Ceralas Multiwavelength 980/1470nm Diode Laser

90164

#### 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 Ceralas Multiwavelength 980/1470 Diode Laser 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. Multiwavelength laser is further indicated for laser assisted lipolysis

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
- Synovectomy
- 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: منها

15

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

\\DĊ. 061218/000001 - 2831829 v2

510(k) Number K090164

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

K090164

Page ② of ④

- 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 turnors
- 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:

16

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

510(k) Number K090164

\\\DC - 061213/000001 - 2831829 v2

{9}------------------------------------------------

KOGJ164

ge of (4)

- 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

# Neurosurgerv

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

17

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

\\\DC - 061213/000001 - 2831829 v2

510(k) Number_

er K090164

{10}------------------------------------------------

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.

Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR

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

k090164

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Oslen Jensen

Page 4 of 4

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

510(k) Number K090164

II. II