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.

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; 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.

Device Description

The Cerals D Diode Laser operates with a power range of 1-50W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end. There is no difference between the laser that is subject of this 510(k) and the previously cleared Ceralas D Diode laser.

AI/ML Overview

The provided text is a 510(k) summary for the Ceralas Diode Laser System. This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through clinical trials and performance data in the same way.

Therefore, the document explicitly states: "Performance Data: None required."

This means that the manufacturer did not conduct a study to demonstrate the device meets acceptance criteria as would be done for a new device requiring such validation. Instead, the substantial equivalence is based on the device being identical to a previously cleared device (the Ceralas D Diode Laser System) and having the same intended use.

Consequently, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies because these were not part of this 510(k) submission. The FDA cleared the device based on its substantial equivalence to an already cleared device, which implies that the predicate device had previously established its safety and effectiveness.

Summary

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

K 99 3 911

pg. 1 of 4

510(k) Summary Ceralas Diode Laser System

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

CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611

Contact Person: Carol J. Morello, V.M.D. Date prepared: August 17, 1999

Name of Device and Name/Address of Sponsor

Ceralas Diode Laser System (Model D) CeramOptec, Inc. 515 Shaker Road East Longmeadow, MA 01028

Classification Name

Surgical laser

Predicate Device

Ceralas D Diode Laser System

Intended Use

See the attached pages 1-3 for a list of indications for use.

Performance Data

None required.

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

'993911

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 .

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

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

K953911

Py 3.5 4

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 .

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

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

125539//

Bas 40 / 4

. 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 .

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized human profile in the negative space.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2000

Carol J. Morello, V.M.D. Regulatory Affairs CeramOptic, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Re: K993911 Trade Name: Ceralas D Diode Laser System Models D15, D25, D50 Regulatory Class: II Product Code: GEX Dated: November 16, 1999 Received: November 17, 1999

Dear Dr. Morello:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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

Page 2 - Carol J. Morello, V.M.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

of 4 Page 1

510(k) Number (if known): K 99 3911

Device Name:_feralas D_Diode Laser System Models D15, D25, D50

Indications For Use:

The attached list of indications is in addition to the already cleared indications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Optional Format 3-10-98)

Timoth Payne

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_ 19

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

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 ●

Nuwell

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_ K99391

Prescription Use (Per 21 CFR 801.109)

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 ●

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

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 .

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 .

Thunef Lage

(Division Sien-Off Division of General Restorative Devices 510(k) Number __ K99391

Prescription Use
(Per 21 CFR 801.109)

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

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 .

Nemoff Luz

(Division Sign-Off) Division of General Restorative Devices 510(k) Number __ K993911

× Prescription Use __ (Per 21 CFR 801.109)

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.