(97 days)
Not Found
No
The description focuses on basic laser functions, parameter settings, and pre-determined settings, with no mention of AI or ML capabilities.
Yes
The device is described for various surgical procedures, including incisions, excisions, and treatments for specific conditions like aphthous ulcers and diseased soft tissue, which directly relate to the treatment or amelioration of a disease or injury.
No
The device description and intended use clearly state that the SIROLaser Advance is a laser system for dental soft tissue surgery, performing functions like incision, excision, hemostasis, coagulation, and vaporization. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states it is a "Diode Laser System" comprised of a "laser unit with handpiece, laser fibers of different diameters, bendable tips, and a wireless foot control," which are all hardware components. The performance studies also include validation testing of both hardware and software functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The SIROLaser Advance is a laser system used for surgical procedures on soft tissue within and outside the mouth. It directly interacts with the patient's tissue for cutting, coagulation, and other therapeutic purposes.
- Lack of Specimen Analysis: The description does not mention the collection, preparation, or analysis of any biological specimens. The device's function is not based on analyzing samples taken from the body.
The device is a therapeutic surgical device, not a diagnostic one.
N/A
Intended Use / Indications for Use
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
Indications for use are the following applications: 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 deseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphthous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SIROLaser Advance is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit with handpiece, laser fibers of different diameters, bendable tips, and a wireless foot control.
The SIROLaser Advance has the following basic functions
- Ability to emit laser radiation either in continuous wave mode (cw) or . chopped mode
- Setup and display of treatment parameters: .
- o power,
- o treatment time,
- chop frequency o
- o duty cycle
- Selection of predetermined settings for different indications ●
- Upgradeable firmware .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra- and extra-oral
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)
Performance testing to validate the safety and effectiveness of the SIROLaser Advance includes electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
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.
Sirona SIROLaser (K053161), Kavo Gentle Ray 980 (K072262), Ivoclar Odyssey Navigator (K062258), Ceramoptec Ceralas D15 (K983058, K991891)
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
. 1 of 2 K092660
DEC = 3 2009
. S
510(k) Summary for Sirona Dental Systems SIROLaser Advance
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle Telephone: 49 6251 16 32 94
October 30, 2009 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | SIROLaser Advance |
|---|---|
| Common / usual name: | Dental Soft Tissue Laser' |
| Classification Names: | Laser instrument, surgical, powered. |
3. PREDICATE DEVICE
SIROLaser, Kavo Gentle Ray 980, Ivoclar Odyssey Navigator, Ceramoptec Ceralas D15
4. INTENDED USE
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
Indications for use are the following applications: 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 deseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphthous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.
1
- 2.of 2 ks92660
ડ. DEVICE DESCRIPTION
The SIROLaser Advance is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit with handpiece, laser fibers of different diameters, bendable tips, and a wireless foot control.
The SIROLaser Advance has the following basic functions
- Ability to emit laser radiation either in continuous wave mode (cw) or . chopped mode
- Setup and display of treatment parameters: .
- o power,
- o treatment time,
- chop frequency o
- o duty cycle
- Selection of predetermined settings for different indications ●
- Upgradeable firmware .
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The Sirona Dental Systems SIROLaser Advance Device is substantially equivalent to Sirona SIROLaser (K053161), Kavo Gentle Ray 980 (K072262), Ivoclar Odyssey Navigator (K062258) and Ceramoptec Ceralas D15 (K983058, K991891). Performance testing to validate the safety and effectiveness of the SIROLaser Advance includes electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol, which is often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The caduceus is depicted as a stylized design with a staff and intertwined snakes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC - 3 2009
Sirona Dental Systems GmbH % Mr. Fritz Kolle Fabrikstrasse 31 D-64625 Bensheim Germany
Re: K092660
Trade/Device Name: SIROLaser Advance Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 30, 2009 Received: November 03, 2009
Dear Mr. Kolle:
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 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
3
Page 2 -- Mr. Fritz Kolle
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
erely yours,
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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p. 1 of 1 | K092660
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SIROLaser Advance
Indications for Use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
Indications for use are the following applications: marginal and interdental gingiva and epithelial lining of free gingiva, 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 deseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphthous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Karen S. Bury for NRO
Division Sign-Off
Sirona Dental Systems special 510(k) SIROLaser Advance
August 26.19800 Surgical, Orthopedic, - Restorative Devices Page vii
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