(21 days)
No
The document describes a laser system with expanded indications for use. There is no mention of AI or ML in the intended use, device description, or any other section. The performance studies section indicates none were required, which is typical for devices without complex algorithms like AI/ML.
Yes
The device is described as a "Laser System" used for various dental indications and is cleared by the FDA for therapeutic procedures like coagulation, decontamination, frenectomy, gingivectomy, and pulpotomy.
No
The device, a Ceralas D Laser System, is indicated for various dental surgical procedures such as draining fistulas, frenectomy, gingivectomy, and pulpotomy. Its function is to perform therapeutic actions, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description explicitly states it is a "Diode Laser" system with a power range and delivery systems consisting of optical fiber, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description and intended use clearly indicate that the Ceralas D Laser System is a surgical laser used for various dental procedures performed directly on the patient's tissues (e.g., gingivectomy, frenectomy, pulpotomy). It does not involve testing samples taken from the body.
The information provided focuses on a medical device used for treatment and surgical procedures, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System that has already been cleared by FDA (K983058) for use in the following dental indications: draining fistulas, coagulation and decontamination of extraction sites, frenectomy, excisional biopsy, operculectomy, implant uncovering, gingivectomy, gingivoplasty, degranulation of infrabony defects, enucleate apical troughing for crown and bridge, apthus ulcers, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, exposure of enamel for orthodontic brackets, and surgical exposure to aid in eruption. The purpose of this submission is to expand the indications for use to include pulpotomy and pulpotomy as an adjunct to root canal therapy.
Product codes
GEX
Device Description
The Cerals D Diode Laser operates with a power range of 1-15W 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
None required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
991891
JUN 2 4 1999
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 Morello, V.M.D. Date prepared: June 1, 1999
Name of Device and Name/Address of Sponsor
Ceralas Diode Laser System (Model D15) CeramOptec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Classification Name
Surgical laser
Predicate Device
Ceralas Diode Laser System (Model D15) Premier Laser System'Pegasus Nd: YAG Laser
Intended Use
The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System that has already been cleared by FDA (K983058) for use in the following dental indications: draining fistulas, coagulation and decontamination of extraction sites, frenectomy, excisional biopsy, operculectomy, implant uncovering, gingivectomy, gingivoplasty, degranulation of infrabony defects, enucleate apical troughing for crown and bridge, apthus ulcers, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, exposure of enamel for orthodontic brackets, and
1
surgical exposure to aid in eruption. The purpose of this submission is to expand the indications for use to include pulpotomy and pulpotomy as an adjunct to root canal therapy.
The Cerals D Diode Laser operates with a power range of 1-15W 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 previously cleared Ceralas D Laser System and the device subject to this 510(k)submission. The Ceralas D Laser System's principles of operation, function and intended use are similar to Premier Laser System's Pegasus Nd: YAG laser system and no new questions of safety or effectiveness are raised.
Performance Data
None required.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1999
Carol J. Morello, VMD Manager, Regulatory Affairs CeramOptec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Re: K991891
Trade Name: Ceralas Diode Laser System (Model D15) Regulatory Class: II Product Code: GEX Dated: June 1, 1999 Received: June 3, 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 vour 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.
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Page 2 - Carol J. Morello, VMD
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,
- Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of I
510(k) Number (if known): ≤ 991891
Device Name: Ceralas D Diode Laser System
Indications For Use:
ﺮ
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
NOTE: These are additional indications to the already cleared indications for market release in K983058.
(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)
Acosta
Divisio [ Sision 5 : O(k) Nun