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 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
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
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.

Device Description

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

AI/ML Overview

The provided text is a 510(k) summary for the Biolitec Inc.'s 180W Ceralas Diode 980nm Laser System (Model D180). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way one would for novel AI or diagnostic devices.

The laser device described is a surgical tool, and its "acceptance criteria" are related to its safety and effectiveness in achieving its intended surgical functions, which are demonstrated through its technological characteristics and intended uses being substantially equivalent to a predicate device that has already been cleared by the FDA.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, does not apply to this 510(k) summary for a surgical laser.

Instead, the "study" demonstrating its acceptance is the comparison to the predicate device as outlined in the "Substantial Equivalence" section.

Here's how to interpret the provided information in the context of a medical device submission demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device operates without new safety concerns compared to predicate.	"The minor technological differences between the Ceralas D 180 and its predicate devices raise no new issues of safety or effectiveness."
Effectiveness: Device performs surgical functions as intended and as effectively as predicate.	"Performance data demonstrate that the Ceralas D 180 is as safe and effective as the predicate devices."
Intended Use: Device's intended uses are the same as or very similar to the predicate.	"The Ceralas D 180 has the same intended uses and similar indications... as its predicate devices."
Technological Characteristics: Device possesses similar technological features and operating principles to the predicate.	"The 180W Ceralas D 980 has the same technological characteristics as the cleared 150W Ceralas D 980." and "The Ceralas D 180 has the same... technological characteristics, and principles of operation as its predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:
This concept is not applicable here. There is no "test set" in the sense of a dataset for an AI or diagnostic algorithm. The "test" is the comparison against the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This concept is not applicable. "Ground truth" for this type of device is established by the existing regulatory clearance and long-term clinical use of the predicate device, and the general understanding of laser physics and surgical applications. There isn't a specific set of experts adjudicating performance for this submission in the way one would for a diagnostic study.

4. Adjudication Method:
Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is for evaluating human performance, often with and without AI assistance for interpretation tasks. This is a surgical laser, not an interpretive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a surgical device requiring human operation, not a standalone algorithm.

7. The Type of Ground Truth Used:
For this submission, the "ground truth" for demonstrating substantial equivalence is established based on the prior FDA clearance of the predicate device (Biolitec's 150W Ceralas D 980nm Diode Laser, K072106). The assumption is that the predicate device is already deemed safe and effective for its indicated uses.

8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning device.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

In summary: The provided 510(k) summary is for a surgical laser system seeking clearance based on substantial equivalence to an already approved predicate device. The "study" demonstrating its acceptability is not a clinical trial in the traditional sense, but rather a comparative analysis of its technical specifications and intended uses against those of the predicate device. The evidence presented focuses on showing that the new device does not raise new issues of safety or effectiveness compared to the predicate, due to their similar characteristics and principles of operation.

Summary

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

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

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

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

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

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

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

\\DC - 061213/000001 - 2812694 v2

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

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.

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

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.

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

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 (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. Mulhausen

Mark N. Melkerson 1 Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

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

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

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

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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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.