(65 days)
Not Found
No
The description focuses on basic laser functions, parameter settings, and predetermined settings, with no mention of AI/ML terms or capabilities.
Yes
The device is described as a "Diode Laser System for dental soft tissue surgery" with an extensive list of therapeutic applications, including incision, excision, hemostasis, coagulation, and vaporization of soft tissue for various dental procedures.
No.
The device description and intended use indicate that the SIROLaser is used for surgical cutting, ablation, and modification of soft tissue. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description explicitly states it is a "Diode Laser System" comprised of a "laser unit, laser fibers, hand pieces, tips, and a finger or a foot switch," indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's soft tissue (intra- and extra-oral surgery). IVDs are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health.
- Device Description: The device is a laser system designed to emit laser radiation for surgical purposes. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the SIROLaser is a surgical device, not an IVD.
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, openculectomy, 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
GEX
Device Description
The SIROLaser is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit, laser fibers of different diameters hand pieces and tips of different angulations, a finger or a foot switch.
The SIROLaser has the following basic functions
- Ability to emit laser radiation either in continuous wave mode (cw) or . chopped mode (laser radiation is switched on and off with a presetable frequency and a duty cycle of 1:1)
- Setup and display of treatment parameters: .
- o power,
- o treatment time,
- chop frequency o
- 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 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)
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
for
053161
Sirona Dental Systems SIROLaser
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
| Contact Person: | Fritz Kolle |
|---|---|
| Telephone: | 49 6251 16 32 94 |
Date Prepared: October 9, 2005
2. DEVICE NAME
| Proprietary Name: | SIROLaser |
|---|---|
| Common / usual name: | Dental Soft Tissue Laser |
| Classification Names: | Laser instrument, surgical, powered |
3. PREDICATE DEVICE )
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, openculectomy, 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
Sirona Dental 510(k) Summary SIROLaser
October 9, 2005
APPENDIX F • Page 1 of 2
1
diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.
ട. DEVICE DESCRIPTION
The SIROLaser is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit, laser fibers of different diameters hand pieces and tips of different angulations, a finger or a foot switch.
The SIROLaser has the following basic functions
- Ability to emit laser radiation either in continuous wave mode (cw) or . chopped mode (laser radiation is switched on and off with a presetable frequency and a duty cycle of 1:1)
- Setup and display of treatment parameters: .
- o power,
- o treatment time,
- chop frequency o
- Selection of predetermined settings for different indications .
- . Upgradeable firmware
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The Sirona Dental Systems SIROLaser Device is substantially equivalent to the Ceramoptec Ceralas D15 (K983058, K991891) sold latterly under the Biolitec brand name SmilePro™ 980. Performance testing to validate the safety and effectiveness of the SIROLaser includes electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
Sirona Dental 510(k) Summary SIROLaser
October 9, 2005
APPENDIX F . Page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized graphic of three human figures in profile, stacked on top of each other. The figures are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2006
Sirona Dental Systems GmbH c/o Mr. Stefan Preiss TUV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K053161 Trade/Device Name: SIROLaser 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: December 30, 2005 Received: January 3, 2006
Dear Mr. Preiss:
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
3
KOSSIV 510(k) Number (if known):
SIROLaser -Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
vaportations for use are the following applications: marginal and interdental gingiva and mithelial lining of free gingiva, frenectomy frenotomy, biopsy, operculectomy, Implant epharenary, gingivectomy, gingival troughing crown lengthening, hemostasis of 1000 viry give epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted paphonomic of hyperplastic tissues, treatment of aphthous ulcers, leukoplakia, sulcular toom, removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.
Prescription Use - X (Part 21 CER 801 Subpart D) ( )|