(77 days)
Not Found
No
The document describes a laser system for dental procedures and teeth whitening. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses on the laser technology and its components.
Yes
The device is described for a variety of dental procedures including incision, excision, vaporization, ablation, and coagulation of oral soft tissues, as well as treatment of canker sores, herpetic and aphthous ulcers. These are all therapeutic actions.
No.
The device description and intended use indicate that the Claros nano Dental Laser System is used for therapeutic and aesthetic procedures like incision, excision, vaporization, and teeth whitening, rather than for diagnosing conditions.
No
The device description explicitly states that the system is comprised of hardware components including a light/laser system console, delivery devices, handpieces, and protective eyewear, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Claros nano Dental Laser System is a therapeutic device that uses laser energy to perform surgical procedures on oral soft tissues, periodontal tissues, and for teeth whitening. It directly interacts with the patient's body for treatment purposes.
- Lack of Diagnostic Testing: The description does not mention any analysis of biological samples or diagnostic testing. Its intended uses are all related to surgical intervention and cosmetic procedures.
Therefore, the Claros nano Dental Laser System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Claros nano Dental Laser System has the following indications for use:
Dental Soft Tissue Indications Including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, and Vestibuloplasty.
*For use on adult and pediatric patients
Laser Periodontal Procedures
Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Tooth Whitening
Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Claros nano Dental Laser System is a variant of the Claros Dental Laser System. It is a portable laser that uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros nano is used for multiple soft tissue, periodontal, and teeth whitening applications.
The Claros nano Dental Laser System is comprised of the following main components:
- a light/ laser system console (including software, a display panel and controls);
- delivery devices;
- one or more handpieces; and
- protective eye wear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, pulpal tissues, periodontal pocket, teeth
Indicated Patient Age Range
adult and pediatric patients
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)
The Claros nano Dental Laser System complies with the following standards:
- IEC 60601-1:1988+A1:1991+A2:1995
- IEC 60601-2-22:1995
- IEC 60825-1:1993+A1:1997+A2:2001
- 21 CFR 1040.10 and 1040.11
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.
Biolase LaserSmile, #K030539, Elexxion Claros,#K063152
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
Section 5: 510(k) Summary
The assigned 510(k) number is:
081652
Elexxion AG Company: Schützenstrasse 84 78315 Radolfzell, Germany Telephone: 49 7732 82299-0 Fax: 49-7732 82299-77
AUG 2 8 2008
- Dr. Holger Ernst Contact:
- June 9th, 2008 Date Prepared:
- Claros nano Dental Laser System Proprietary Names:
Surgical Powered Laser Instrument Classification Name:
Dental Diode Laser Common Name:
- · Claros nano Class II, 21 CFR 878.4810, GEX Classification Code:
- Biolase LaserSmile, #K030539 Predicate Devices: Elexxion Claros,#K063152
The Claros nano Dental Laser System is a variant of the Device Description: Claros Dental Laser System. It is a portable laser that
uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros nano is used for multiple soft tissue, periodontal, and teeth whitening applications.
The Claros nano Dental Laser System is comprised of the following main components:
· a light/ laser system console (including software, a display panel and controls);
- · delivery devices;
- · one or more handpieces; and
Please refer to Attachment 1
- · protective eye wear.
Intended Use:
Performance Data:
- The Claros nano Dental Laser System complies with the following standards:
- · IEC 60601-1:1988+A1:1991+A2:1995
- IEC 60601-2-22:1995
- · IEC 60825-1:1993+A1:1997+A2:2001
- · 21 CFR 1040.10 and 1040.11
1
| Substantial Equivalence: | The Claros nano Dental Laser System (and accessories) shares the same or similar indications for use, principles of operation, overall technical and functional capabilities, and therefore is substantially equivalent for use in general and plastic surgery and dentistry for surgical applications to the predicate device identified. |
|---|---|
| Conclusion: | The Claros nano Dental Laser System (and accessories) is substantially equivalent to previously cleared dental devices and raises no new safety or effectiveness issues. |
:
:
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2008
Elexxion AG % Dr. Holger Ernst Head of R&D Technology Schützenstrasse 84 78315 Radolfzell, Germany
Re: K081652
Trade/Device Name: Claros nano Dental Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 9, 2008 Received: June 12, 2008
Dear Dr. Ernst:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. Holger Ernst
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
081652
510(k) Number (if known):
Device Name: Claros nano Dental Laser System
Indications for Use:
Dental Soft Tissue Indications Including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectorny, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectomy, Oral papillectornies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening,
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, and Vestibuloplasty.
*For use on adult and pediatric patients
Laser Periodontal Procedures
Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Tooth Whitening
Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening
Alask N. Miliken
Sip Off
and Neurologi
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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