K Number

Device Name

CERALAS D 980NM DIODE LASER, MODELS D15 AND D25

Manufacturer

BIOLITEC, INC.

Date Cleared

2008-01-24

(118 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision. excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue) and laser assisted lipolysis.

Device Description

Not Found

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K993911, K032863, K062321, K983058, K991891, K993002, K964497

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser system for soft tissue surgery and does not mention any AI or ML capabilities.

Therapeutic

No
The device is used for surgical procedures like incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, which are not considered therapeutic but rather interventional or surgical.

Diagnostic

No
The device is described for surgical procedures involving incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, indicating its function as a therapeutic rather than diagnostic tool.

SaMD (Software as a Medical Device)

The device is described as a laser system intended for surgical procedures, which inherently involves hardware components for generating and delivering laser light. The summary does not mention any software-only functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, the Ceralas D 980 is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly describes the device as a surgical laser system used for direct interaction with soft tissue within the body during surgical procedures. This includes incision, excision, vaporization, ablation, hemostasis, and coagulation.
IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing performed on specimens outside the body.

Therefore, the Ceralas D 980 is a surgical device used for therapeutic and procedural purposes directly on living tissue, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Specific Indications for Use

Ear, Nose and Throat and Oral Surgery:

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
Tonsillectomy
Thyroidectomy
Vocal cord polypectomy
Hemiglossectomy
Tracheal stenosis
Oral cavity lesions

Dental Applications:

Intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include:

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
Vestibuloplasty
Excision of lesions
Exposure of unerupted/partially erupted teeth
Leukoplakia
Removal of hyperplastic tissues
Treatment of aphthous ulcers
Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Light activation of bleaching materials for teeth whitening

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:

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
Parathvroidectomy
Laparoscopic cholecystectomy
Thyroidectomy
Resection of organs
Debridement of wounds
Phototcoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities

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

Gynecology:

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

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

Neurosurgery:

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Example includes:

Hemostasis in conjunction with menigiomas

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

Cardiothoracic Surgery:

Incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, including cardiac tissues.

Laser Assisted Lipolysis

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. Specifically for hemostasis and coagulation of soft tissue (including cardiac tissue) and laser assisted lipolysis.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No performance data is being submitted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K993911, K032863, K062321, K983058, K991891, K993002, K964497

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

K072779 Pg 1 of 6

510(k) SUMMARY

Biolitec Inc.'s Ceralas Diode 980nm Laser System (Models D15, D25)

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

Hogan & Hartson 555 13th Street NW Washington DC 20004

Phone: (202) 637-5794 Facsimile: (202) 637-5910

Contact Person: Jonathan S. Kahan

Date Prepared: January 18, 2008

Name of Device and Name/Address of Sponsor

Ceralas D 980nm Diode Laser (Models D15, D25)

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

Common or Usual Name

Diode Laser

Classification Number/Name

Laser, Surgical Diode Laser System 878.4810

Product Code

GEX

Predicate Devices

Ceralas Diode Laser System (Model D) (K993911) Ceralas D 980nm Diode Laser (Models D15, D25) (K032863) Cynosure SmartLipo Laser Nd:YAG Laser System (K062321) JAN 2 4 2008

K072779

pg 2 of 6

Ceralas Diode Laser System (Model D15) (K983058) Ceralas Diode Laser System (Model D15) (K991891) Ceralas Diode Laser System (Model D15) (K993002) Ceralas Diode Laser Systems (Model D15) (K964497)

Intended Use / Indications for Use

Specific Indications for Use

Ear, Nose and Throat and Oral Surgery:

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 carcınoma of the larynx
Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II
Neck dissection
Tonsillectomy
Thyroidectomy
Vocal cord polypectomy
Hemiglossectomy
Tracheal stenosis
Oral cavity lesions

K072779 pg 3 of 6

Dental Applications:

Intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include:

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
Vestibuloplasty
Excision of lesions
Exposure of unerupted/partially erupted teeth
Leukoplakia
Removal of hyperplastic tissues
Treatment of aphthous ulcers
Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
. Pulpotomy
Pulpotomy as an adjunct to root canal therapy
. Light activation of bleaching materials for teeth whitening

Arthroscopy:

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

Menisectomy .
Synovectomy .
Chondromalacia ●

K072779 pg 4 of 6

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:

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
Parathvroidectomy
Laparoscopic cholecystectomy
Thyroidectomy
Resection of organs
Debridement of wounds
Phototcoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities

K072779 pg 5 of 6

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

Gynecology:

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

Endometrial ablation ●
Excision or vaporization of condylomata acuminata .
. Vaporization of cervical intraepithelial neoplasia
Cervical conization .
Menorrhagia .

Neurosurgery:

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Example includes:

Hemostasis in conjunction with menigiomas

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

Cardiothoracic Surgery:

Incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, including cardiac tissues.

Laser Assisted Lipolysis

K072779

pg 6 of 6

Technological Characteristics

The Ceralas D 980 for laser assisted lipolysis has the same technological characteristics as the cleared Ceralas and substantially similar technological characteristics as compared to the Cynosure SmartLipo Iaser.

Performance Data

No performance data is being submitted.

Substantial Equivalence

The Ceralas D is as safe and effective as Biolitec's cleared Ceralas Diode Laser System (K964497, K993911, K032863, K983058, K991891, K993002), as well as the Cynosure SmartLipo Laser Nd YAG Laser System (K062321). The Ceralas D 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 and its predicate devices raise no new issues of safety or effectiveness. Thus, the Ceralas D is substantially equivalent.

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, stacked one above the other.

JAN 24 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072779

Trade/Device Name: Ceralas D 980nm Diode Laser System (Models D15, D25) 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: December 28, 2007 Received: December 28, 2007

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

Page 2 - Mr. Jonathan S. Kahan

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.

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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Millman

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

Enclosure

Indications for Use Statement

510(k) Number (if known):

Ceralas D 980nm Diode Laser System (Models D15, D25) Device Name:

Indications for Use:

The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue) and laser assisted lipolysis.

Specific Indications for Use:

Ear, Nose and Throat and Oral Surgery:

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 .
. Tonsillectomy
. Thyroidectomy
. Vocal cord polypectomy
. Hemiglossectomy
Tracheal stenosis
. Oral cavity lesions

Mark N. Mulheran

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

Neurological

510(k) Number K072774

\DC - 061213/000001 - 2658418 v1

K072779

pg 2 of 5

Dental Applications:

Intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include:

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
. Vestibuloplasty
Excision of lesions .
. Exposure of unerupted/partially erupted teeth
. Leukoplakia
. Removal of hyperplastic tissues
. Treatment of aphthous ulcers
. Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
. Pulpotomy
. Pulpotomy as an adjunct to root canal therapy
Light activation of bleaching materials for teeth whitening .

Arthroscopy:

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

. Menisectomy
. Synovectomy
. Chondromalacia

include:

Mark H. Milken

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

510(k) Number_

K072779

K072779 Pg 3 of 5

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:

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
Phototcoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities

Mark A. Miller

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

§10(k) Number
K072779

K072779

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 .

Gynecology:

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

Endometrial ablation ●
Excision or vaporization of condylomata acuminata .
Vaporization of cervical intraepithelial neoplasia .
Cervical conization .
Menorrhagia .

Neurosurgery:

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Example includes:

Hemostasis in conjunction with menigiomas

Pulmonary Surgery:

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

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

Cardiothoracic Surgery:

Incision, excision, vaporization, ablation, hemostasis, and coagulation on including cardiac tissues.

Laser Assisted Lipolysis

stasis, and coagulation of soft tissue,
Mark A. Millerea

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

§10(k) Number K072774

\\DC - 061213/000001 - 2658418 v1

072779 pg 5 of 5

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. Milburn

(Division Sign-Off) (Division Sign=Only Restorative,
Division of General, Restorative, Division of Occal Devices
and Neurological Devices 022999 510(k) Number_