(14 days)
Premier Laser System' Aurora Diode Laser
Not Found
No
The provided text describes a diode laser system for dental soft tissue procedures and does not mention any AI or ML capabilities.
Yes
The device is intended for various dental indications that involve treating or modifying body tissues, such as frenectomy, biopsy, gingivectomy, and removal of hyperplastic tissues, which are therapeutic interventions.
No
The Ceralas D10 Laser System is intended for various therapeutic dental procedures on soft tissue, such as frenectomy, biopsy, gingivectomy, and debridement, rather than for diagnosing conditions.
No
The device description explicitly states it is a "Diode Laser" system that operates with a power range and uses optical fiber delivery systems. This indicates it is a hardware device, not software only.
Based on the provided information, the Ceralas D10 Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that the Ceralas D10 Laser System is used for surgical procedures on intraoral and extraoral soft tissue within the patient's body. It is a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- The intended uses are all surgical procedures. The list of indications includes procedures like frenectomy, biopsy, gingivectomy, etc., which are all direct interventions on living tissue.
- There is no mention of analyzing biological samples. The description focuses on the laser's power and delivery system for tissue interaction.
Therefore, the Ceralas D10 Laser System is a medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ceralas DlO Diode laser is indicated for the following dental indications on intraoral and extraoral soft tissue (including marginal and interdental gingiva : and epithelial lining of free gingiva); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor sites, 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, and pulpotomy as an adjunct to root canal therapy.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Ceralas D10 Laser System 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva), periodontal pocket
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.
Premier Laser System' Aurora Diode Laser
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.
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K992773
SEP - 1 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 (413) 525-0600 Phone: 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
Intended Use
The Ceralas D10 Laser System that is the subject of this 510(k) notice is intended for the following dental indications on intraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenctomy, frenotomy, biopsy, operculectorny, 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
MITRE ATT&CK
1
aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy and pulpotomy as an adjunct to root canal therapy.
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.. The Ceralas D10 Laser System's principles of operation, function and intended use are similar to Premier Laser System's Aurora Diode Laser System and no new questions of safety or effectiveness are raised.
Performance Data
None required.
Image /page/1/Picture/7 description: The image shows a blurry, low-resolution image of some text. The text is illegible due to the poor image quality. It is difficult to determine the content or meaning of the text without a clearer image.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 1999
Carol J. Morello, VMD Manager, Regulatory Affairs CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
K992773 Re:
Trade Name: Ceralas D10 810nm Diode Laser System Regulatory Class: II Product Code: GEX Dated: August 17, 1999 Received: August 18, 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.
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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,
Colin M. Witwer, 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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Page_of_______________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K992773
Device Name: Ceralas D10 810nm Diode Laser System
Indications For Use:
く
The Ceralas DlO Diode laser is indicated for the following dental indications on intraoral and extraoral soft tissue (including marginal and interdental gingiva : and epithelial lining of free gingiva); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor sites, 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, and pulpotomy as an adjunct to root canal therapy.
(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) | X |
|---|---|
| ------------------------------------------ | --- |
(Optional Format 3-10-98)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992773 |