(77 days)
Ceralas D Diode Laser System
Not Found
No
The document describes a diode laser system for various surgical applications and does not mention any AI or ML components.
Yes.
The device is indicated for various surgical procedures such as excision, ablation, coagulation, and vaporization of tissues across multiple anatomical sites (e.g., ENT, gastroenterology, general surgery, urology, gynecology, neurosurgery, pulmonary surgery), which are all therapeutic interventions.
No
Explanation: The device is described as a surgical laser used for various procedures such as excision, ablation, coagulation, hemostasis, and vaporization of tissues. It is intended for therapeutic interventions rather than for diagnosing conditions.
No
The device description explicitly states it is a "Diode Laser" and describes its power range and delivery system using optical fibers, which are hardware components. The indications for use also describe surgical procedures performed with a laser, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended uses clearly indicate that this device is a surgical laser system used for direct interaction with tissues within the body (hemostasis, incision, excision, ablation, coagulation, vaporization, photocoagulation, debulking, dermabrasion). It is used during surgical procedures on various anatomical sites.
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens taken from the body. Its function is to modify or remove tissue directly.
Therefore, the Ceralas D Diode Laser System, as described, falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
See the attached pages 1-3 for a list of indications for use.
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.
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 .
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose, Throat, oral cavity, joint tissues, upper and lower gastrointestinal tracts, skin, abdominal, rectal, skin, fat or muscle tissue, urological tissues, gynecological tissue, soft tissue (neurosurgery), pulmonary system.
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)
None required.
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.
Ceralas D Diode Laser System
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
§ 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.
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.
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.
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
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)