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 150W Ceralas D980 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
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
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 acuminata
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.

Device Description

The 150W Ceralas D980 has the same technological characteristics as the cleared 100W Ceralas D980 and substantially similar technological characteristics as compared to the INTERmedic Diode Laser and the Xintec Vectra Diode Laser.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Biolitec Inc.'s 150W Ceralas Diode 980nm Laser System). It discusses the device's intended use, indications for use, technological characteristics, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or specific studies proving the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence to already cleared devices, which is the regulatory pathway used for this laser system. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new safety or effectiveness concerns compared to predicate devices. It does not typically involve reporting on a study with specific acceptance criteria in the way you've outlined for performance analysis.

Therefore, I cannot populate the requested table or answer most of your questions as the information is not present in the provided text.

Here's what I can extract based on your questions, acknowledging the significant gaps due to the nature of the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified in the document. The document states "Performance data demonstrate that the Ceralas D150 is as safe and effective as the predicate devices," but no details on specific studies, sample sizes, or data provenance are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/specified. This type of information is typically found in studies evaluating diagnostic or AI-driven devices, which is not the case here. This document pertains to a surgical laser system.

4. Adjudication method for the test set

Not applicable/specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a surgical laser system, not an AI-driven or diagnostic imaging device that would typically involve a multi-reader multi-case study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a surgical laser system, so the concept of an "algorithm only" performance study is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/specified. The document does not describe studies that would rely on "ground truth" as typically defined for diagnostic or AI algorithm evaluation. The "performance data" mentioned generally refers to demonstrating the device's physical operational parameters and
(presumably) safety profile in comparison to existing devices.

8. The sample size for the training set

Not applicable/specified. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable/specified. There is no mention of a "training set" or "ground truth" in this context.

Summary

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

510(k) SUMMARY

K072106

Biolitec Inc.'s 150W Ceralas Diode 980nm Laser System (Model D150)

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: July 26, 2007

Name of Device and Name/Address of Sponsor

150W Ceralas D 980nm Diode Laser (Model D150)

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 100W Ceralas D 980nm Diode Laser ((K050824, K071295)

INTERmedic Diode Laser Family 890nm and 980nm (K053540)

Xintec Vectra Diode Laser (K060114)

AUG 3 0 2007

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

Intended Use / Indications for Use

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:

. 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:

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

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 .

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

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. 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.

Technological Characteristics

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

Substantial Equivalence

The 150W Ceralas D980 is as safe and effective as Biolitec's 100W Ceralas D 980nm Diode Laser (K0071295), INTERmedic's Diode Laser Family 890nm and 980nm (K053540), and Xintec's Vectra Diode Laser (K060114). The Ceralas D150 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 D150 and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Ceralas D150 is as safe and effective as the predicate devices. Thus, the Ceralas D150 is substantially equivalent to the predicate devices.

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

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is depicted in a simple, black-and-white design.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolitec. Inc. c/o Mr. Johnathan S. Kahan Hogan & Hartson, LLP 555 Thirteenth Street, Northwest Washington, DC 20004

Re: K072106 Trade/Device Name: 150W Ceralas D 980nm Diode Laser (Model D150) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: July 31, 2007 Received: July 31, 2007

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of August 30, 2007.

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 (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.

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

Page 2 - Mr. Johnathan S. Kahan

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 (OS) 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 continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

elgmee

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

K072106

Indications for Use Statement

510(k) Number (if known):

150W Ceralas D 980nm Diode Laser (Model D150) Device Name:

Indications for Use:

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

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

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 .
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 .

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

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
t 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
t Endoscopic pulmonary applications

Dental Applications

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

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.

Prescription Use X (Part 21 C.F.R. 801 Subpart D)	AND/OR	Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
-----------------------------------------------------	--------	-------------------------------------------------

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

510(k) Number	L072106
---------------	---------

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.