K Number

Device Name

CERALAS D 980NM DIODE LASER, MODELS D15 AND D25

Manufacturer

BIOLITEC, INC.

Date Cleared

2008-07-08

(90 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 noncontact 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, and ophthalmology. This Ceralas D 980 is specifically indicated for laser assisted lipolysis.

Device Description

The Ceralas D has the same technological characteristics as the cleared Ceralas and substantially similar technological characteristics as compared to the Quanta System Diode Medical Laser Family.

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

K072779, K072034

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a laser device for soft tissue surgery and does not mention AI or ML in its description, intended use, or performance studies.

Therapeutic

Yes
The device is intended for surgical procedures such as incision, excision, vaporization, and ablation of soft tissues, which are therapeutic interventions.

Diagnostic

No
The device is described as being for "delivery of laser light to soft tissue in the contact or noncontact mode during surgical procedures," and its indicated uses are for various surgical procedures involving incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue. These are therapeutic, not diagnostic, actions.

SaMD (Software as a Medical Device)

The device description and intended use clearly describe a laser device intended for surgical procedures, which is a hardware-based medical device. There is no mention of software being the primary or sole component.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes a surgical laser used for direct interaction with soft tissue during various surgical procedures. This is a therapeutic device, not a diagnostic one.
Device Description: The description focuses on the technological characteristics of a laser, which is consistent with a surgical tool.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.

Therefore, the Ceralas D 980 is a surgical laser, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or noncontact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, 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, and ophthalmology. This Ceralas D 980 is specifically indicated for 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.
Dental Applications: Intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva).
Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization of joint tissues during arthroscopic surgery.
Gastroenterology: Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures.
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.
Urology: Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues.
Gynecology: Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue.
Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue.
Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system.
Cardiothoracic Surgery: Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue, including cardiac tissues.
Laser Assisted Lipolysis
Ophthalmology: The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology.

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 (Intraoral and extraoral soft tissue including marginal and interdental gingiva and epithelial lining of free gingiva), joints (arthroscopy), upper and lower gastrointestinal tracts, skin, abdominal, rectal, fat or muscle tissue, urological tissues, gynecological tissue, pulmonary system, cardiac tissues, ophthalmology.

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.

K072779, K072034

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

KOS(015 Pgi 1 46

510(k) SUMMARY

IJUL - 8 2008

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

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

Hogan & Hartson, LLP 555 13th Street, NW Washington, DC 20004

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

Contact Person: Jonathan S. Kahan

April 09, 2008 Date Prepared:

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 Name

878.4810 - Laser, Surgical Diode Lascr System

Product Code

GEX

Predicate Devices

Biolitec's Ceralas D 980nm Diode Laser (Models D15, D25) (K072779) Quanta System Diode Medical Laser Family (K072034)

Koriols

Intended Use / Indications for Use:

Indications for Use:

The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or noncontact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, 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, and ophthalmology. This Ceralas D 980 is specifically indicated for 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 car, 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

K081015

pg 3 of 6

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 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

xlois

pg 4 of 6

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 t

Koglois

pg 5 of 6

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, and coagulation of soft tissue, including cardiac tissues.

Laser Assisted Lipolysis

Ophthalmology:

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology. Examples include:

Open Dacryocystorhinostomy .
Endonasal Dacryocystorhinostomy .
Blepharoplasty .
Oculoplastics .
Tumor excision and biopsy .
Eyelid reconstruction �

K081615 pg 6 of

Technological Characteristics

The Ceralas D has the same technological characteristics as the cleared Ceralas and substantially similar technological characteristics as compared to the Quanta System Diode Medical Laser Family.

Performance Data

No performance data is being submitted.

Substantial Equivalence

The Ceralas D is as safe and effective as Biolitec's cleared Ceralas D 980nm Diode Laser (K072779) and the Quanta System Diode Medical Laser Family (K072034). The Ceralas D has the same intended uses and similar indications, technological characteristics, and principles of operation as the identified predicate devices, so there are no new issues of safety or effectiveness. Thus, the Ceralas D is substantially equivalent to the identified predicate devices.

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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2008

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

Re: K081015

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: April 9, 2008 Received: April 9, 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

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 yours,

Mark M. Mulkerson

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

Enclosure

K081015

pg 1 of 5

Indications for Use Statement

510(k) Number (if known):

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

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

Aulber Breen

Division of Gene and Neurological Device:

510(k) Number K081015

। ୧

K081015

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 .

Carla Sue Ott

ivision of General, Restorative, and Neurological Devices

510(k) Number K081015

K08/015

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

extremiities

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number 2081015

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, and coagulation of soft tissue, including cardiac tissues.

Laser Assisted Lipolysis

Aarlene Buchan

Division of General, Restorative. and Neurological Devices

\DC - 061213/000001 - 2707069 v3

510(k) Number_k081015

K081015

pg 5 of 5

Ophthalmology:

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology. Examples include:

Open Dacryocystorhinostomy .
Endonasal Dacryocystorhinostomy .
Blepharoplasty .
Oculoplastics .
Tumor excision and biopsy .
Eyelid reconstruction ●

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)

Barbara Buent

Division of General, Restorative, and Neurological Devices

510(k) Number K081015