SIROLASER

K053161 · Sirona Dental Systems GmbH · GEX · Jan 18, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053161
• Device Name: SIROLASER
• Applicant: Sirona Dental Systems GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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 diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.

Device Story

SIROLaser is a diode laser system for dental soft tissue surgery. System components include laser unit, fibers, handpieces, tips, and finger/foot switch. Device emits laser radiation in continuous wave (cw) or chopped mode (preset frequency/duty cycle). User sets treatment parameters (power, time, frequency) or selects predetermined settings for specific indications. Used in dental clinics by professionals for soft tissue procedures; output is laser energy for tissue interaction. Benefits include precise tissue management, hemostasis, and vaporization. Firmware is upgradeable.

Clinical Evidence

No clinical data. Performance validation was limited to bench testing, including electrical safety, electromagnetic compatibility, and hardware/software function verification.

Technological Characteristics

Diode laser system. Operates in continuous wave or chopped modes. Includes laser unit, fibers, handpieces, tips, and foot/finger switches. Features adjustable power, treatment time, and chop frequency. Firmware is upgradeable.

Indications for Use

Indicated for intra- and extra-oral soft tissue dental surgery, including incision, excision, hemostasis, coagulation, and vaporization. Applications include gingivectomy, frenectomy, biopsy, implant recovery, crown lengthening, abscess drainage, and periodontal pocket debridement.

Regulatory Classification

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.

Predicate Devices

• Ceralas D15 (K983058, K991891)

Submission Summary (Full Text)

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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

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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

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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

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## 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) ( )|<

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sirona Dentaj Systems 510(k) October 9, 2005
Sirolaser

** (Division Sign-Off)

Division of General, Restorative. and Neurological Devices

510(k) Number_k053161

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