(81 days)
See the attached pages 1-3 for a list of indications for use.
The attached list of indications are in addition to the already cleared indications.
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
- 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 .
Ophthalmology
Retinal photocogulation Diabetic retinopathy
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 .
The Cerals D10 Diode Laser operates with a power range of 1-10W 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.
The Ceralas Diode Laser System (Model D10) is a surgical laser.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
-
A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Not specified. Not specified. Explanation: The document explicitly states "None required" under the "Performance Data" section. This indicates that specific acceptance criteria and performance data were not deemed necessary for this 510(k) submission, likely due to substantial equivalence to already cleared predicate devices. The submission relies on demonstrating that the device has principles of operation, function, and intended use similar to predicate devices, and that it raises no new questions of safety or effectiveness.
-
Sample sizes used for the test set and the data provenance:
No test set data is provided, as performance data was not required. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no performance data based on a test set was required or provided. -
Adjudication method for the test set:
Not applicable, as no performance data based on a test set was required or provided. -
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 device is a surgical laser, not an AI-assisted diagnostic tool. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a surgical laser, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no performance data requiring ground truth was presented. -
The sample size for the training set:
Not applicable, as this is neither an AI/ML device nor is a training set mentioned. -
How the ground truth for the training set was established:
Not applicable, as this is neither an AI/ML device nor is a training set mentioned.
{0}------------------------------------------------
FEB 1 2000
993828
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 D10) CeramOptec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Classification Name
Surgical laser
Predicate Device
Premier Laser System' Aurora Diode Laser Biolase Twilight Diode Laser
Intended Use
See the attached pages 1-3 for a list of indications for use.
The Cerals D10 Diode Laser operates with a power range of 1-10W 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 are no technological differences between the Ceralas D10 Laser System and the Premier Laser Systems Aurora Diode Laser. or the Biolase Twilight Diode Laser. The
{1}------------------------------------------------
Ceralas D10 Laser System's principles of operation, function and intended use are similar to Premier Laser System's Aurora Diode Laser System and Biolase Twilight Diode Laser and no new questions of safety or effectiveness are raised.
Performance Data
None required.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 1 2000
Carol J. Morello, V.M.D. Regulatory Affairs CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Re: K993828 Trade Name: Ceralas D10 810nm Diode Laser System Regulatory Class: II Product Code: GEX Dated: November 10, 1999 Received: November 12, 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.
{3}------------------------------------------------
Page 2 - Carol J. Morello, V.M.D.
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.
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,
- Werner Jaeger
Sir James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page ! __of_4
510(k) Number (if known): K993821
Device Name:__Ceralas D10 810nm Diode Laser System
Indications For Use:
:
The attached list of indications are 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)
Munell Page
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
(Optional Format 3-10-98)
Prescription Use _____ (Per 21 CFR 801.109)
{5}------------------------------------------------
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:
Russell Lyon
(Division Sign-Off)
- Matrixectomy
2 Prescription Use . (Per 21 CFR 801.109)
ivision of General Restorative Devices
{6}------------------------------------------------
- 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:
(Division Sign-Off) Division of General Restorative Devic 510(k) Number_________________________________________________________________________________________________________________________________________________________________
-
Endometrial ablation ●
くてつける。 このとなります -
Excision or vaporization of condylomata acuminata ◆
Prescription Use . X (Per 21 CFR 801.109)
{7}------------------------------------------------
- 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 .
Ophthalmology
Retinal photocogulation Diabetic retinopathy
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 .
(Division Sign-Off)
Division of General Restorative Devices 510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
§ 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.