(50 days)
No
The device description focuses on the hardware components and laser technology, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for various medical applications on soft tissue, such as frenectomy, biopsy, gingivectomy, and treatment of aphthous ulcers, which are therapeutic interventions.
No
The Ceralas D Laser System is described as a "surgical laser" indicated for various soft tissue procedures like frenectomy, biopsy, gingivectomy, etc. These are treatments, not diagnostic processes. The description also mentions it is used to "deliver laser radiation to the target tissues," which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a laser diode, cooling module, optics module, control panel, power supply, and fiber optic delivery systems.
Based on the provided information, the Ceralas D Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on intraoral and extraoral soft tissue. This involves treating the patient directly, not analyzing samples taken from the patient outside the body.
- Device Description: The device description details a surgical laser system designed to deliver laser radiation to target tissues for therapeutic purposes. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Ceralas D Laser System's function is to perform surgical procedures on living tissue.
N/A
Intended Use / Indications for Use
The Ceralas D Laser System has been cleared as a surgical instrument intended for incision, excision, hemostasis, coagulation, and vaporization of soft tissue in open and closed endoscopic procedures in general surgery, urology, gynecology, neurosurgery, gastroenterology, plastic surgery, dermatology, and otolaryngology. Specific indications for the previously cleared Ceralas D Laser System include tonsillectomy, thyroidectomy, vocal cord polypectomy, hemiglossectomy, tracheal stenosis, neck dissection, and oral cavity lesions.
The company is expanding the Ceralas D Laser System's indications for use to include the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): 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; and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
Product codes
GEX
Device Description
The Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode; (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFI-shielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module.
The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635nm+10nm. The power output ranges from 1-15 Watts. The delivery systems for the Ceralas D Laser System consist of an optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva)
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)
K951775, K964497, K954316, K974586, K972325, K961269, K961136
Reference Device(s)
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
983058
OCT 21 1998
510(k) Summary Ceralas Diode Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitted by Regulatory Counsel for: CeramOptec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611
Contact Person: Carol Morello, V.M.D. Date prepared: September 1, 1998
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 Systems' Aurora Diode Dental Laser American Dental Technologies Pulsemaster® 1000 ST Dental Diode Laser System American Dental Technologies Pulsemaster® 1000 Nd:YAG Laser
Intended Use
There have been no significant changes to the Ceralas D Laser System since is was cleared by FDA (K951775, K964497). The Ceralas D Laser System has been cleared as a surgical instrument intended for incision, excision, hemostasis, coagulation, and vaporization of soft tissue in open and closed endoscopic procedures in general surgery, urology, gynecology, neurosurgery, gastroenterology,
1
plastic surgery, dermatology, and otolaryngology. Specific indications for the previously cleared Ceralas D Laser System include tonsillectomy, thyroidectomy, vocal cord polypectomy, hemiglossectomy, tracheal stenosis, neck dissection, and oral cavity lesions.
The company is expanding the Ceralas D Laser System's indications for use to include the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): 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; and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
As explained below, the Company's Ceralas D Laser System is substantially equivalent to the previously cleared Ceralas D Laser System (K951775, K964497), Premier Laser Systems' Aurora Diode Dental Laser (K954316, K974586). American Dental Technologies' Pulsemaster® 1000 ST Dental Diode Laser System (K972325), and American Dental Technologies' Pulsemaster® 1000 Nd:YAG Laser (K961269, K961136).
Technological Characteristics and Substantial Equivalence
As stated above, there have been no significant changes to the Ceralas D Laser System since it was cleared by FDA. The Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode; (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFI-shielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module.
The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635nm+10nm. The power output ranges from 1-15 Watts. The delivery systems for the Ceralas D Laser System consist of an optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.
2
Moreover, the optical fiber delivery system has been previously cleared for dental use (K942182).
CeramOptec has made no significant changes to the hardware or software of the Ceralas D Laser since it was cleared by FDA. Likewise, CeramOptec has made no significant changes to its software development process since its previous 510(k) submission for the Ceralas D Laser System. Additionally, the software verification and validation were conducted in accordance with FDA's Guidance Document, "Reviewer Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review."
The principal technological difference between the Ceralas Diode Laser and Premier Laser System's Aurora Diode Dental Laser is that the devices operate at different wavelengths. The Ceralas D Laser's wavelength is 980 ±30mm and the Aurora Diode Dental Laser's wavelength is 805-820mm. However, it is not believed that the difference between the devices' wavelength raise new questions of safety and effectiveness.
The Ceralas D Laser is also similar to American Dental Technologies' Pulsemaster® 1000 ST Diode Dental Laser. Both devices are similar in function and intended use. and are diode lasers which operate in a continuous or pulsed mode with wavelength ranges similar to the Premier Laser System's Aurora Diode Dental Laser. In summary, although there are minor differences between the Ceralas D Laser System and its predicate devices, these differences do not raise new questions of safety and efficacy.
Performance Data
None required.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
CeramOptec, Inc. c/o Jonathan S. Kahan Hogan and Hartson Columbia Square 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
K983058 Re: Ceralas Diode Laser System(Model D15) Trade Name: Regulatory Class: II Product Code: GEX 1998 Dated: September 01, Received: September 01, 1998
Dear Mr. Kahan:
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 The general controls provisions of the Act 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. ਖੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.
4
Paqe 2 - Mr. Jonathan S. Kahan
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 requlation (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.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993058
Ceralas D Laser System Device Name:
Indications For Use:
The Ceralas D Laser System is indicated for the following applications on intraoral The Cordial D 2002 vincluding marginal and interdental gingiva and epithelial ana one free gingiva): frenectomy; frenotomy; biopsy; operculectomy; implant Hillig of recogning; gingivoplasty; gingival troughing; crown lengthening; I covery, ging: rootens), grag-vel 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; and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEE
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Sign-Off | |
|---|---|
| of General Restorative Devices | |
| 510(k) Number | K983058 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)