DOCTOR SMILE A-810 AND B-980 LASERS

K091562 · Lambda Scientific Spa · GEX · Sep 8, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091562
• Device Name: DOCTOR SMILE A-810 AND B-980 LASERS
• Applicant: Lambda Scientific Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 8, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Doctor Smile A-810 Laser is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening. Intra- and extra oral surgery including incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening. Doctor Smile Diode B-980 Laser is intended for use in the following procedure: Surgical applications requiring the ablation, vaporization, excision, incision, haemostasis, or coagulation of soft tissue in medical specialties including dentistry, dermatology, general surgery, gynecology, ophthalmology, pulmonology, otolaryngology, othopedics.

Device Story

Doctor Smile A-810 and B-980 are portable diode lasers (810 nm and 980 nm wavelengths). System consists of laser console with display/software, fiber optic delivery system, handpieces, and protective eyewear. Device transmits laser energy via contact fiber optic delivery to target soft tissue. Used by clinicians in various medical specialties (dentistry, dermatology, surgery, etc.) for ablation, vaporization, excision, incision, haemostasis, and coagulation. Output is controlled laser energy; clinician directs energy to tissue to achieve surgical effect. Benefits include precise tissue management and haemostasis during procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable diode laser system; 810 nm (A-810) and 980 nm (B-980) wavelengths. Contact fiber optic delivery system. Components: console with display/software, fiber optic, handpieces, protective eyewear. Complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and 21 CFR 1040.10/1040.11.

Indications for Use

Indicated for soft tissue surgical procedures including incision, excision, vaporization, ablation, haemostasis, and coagulation. Specific applications include dentistry (periodontal procedures, biopsies, frenectomy, gingivoplasty, implant recovery, pulpotomy, whitening), dermatology, general surgery, gynecology, ophthalmology, pulmonology, otolaryngology, and orthopedics.

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

• Arc Laser GmbH Fox Q-810, Q-980 (K073322)
• Biolase Ezlase (K082938)
• Sirona Sirolaser (K053161)
• Kavo Gentleray 980 (K072262)
• Ceralas 980 (K072779)
• Claros Nano Dental Laser System (K081652)

Submission Summary (Full Text)

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SEP 0 8 2009

Image /page/0/Picture/2 description: The image shows the logo for LAMBDA Scientifica SpA. The logo includes a stylized lambda symbol on the left. To the right of the symbol is the company name, "LAMBDA Scientifica SpA", with the word "LAMBDA" in a larger font size. There is also a signature above the company name.

# 510(K) SUMMARY

| 510(k) owner and submitter | LAMBDA Scientifica S.p.A.<br>Via Retrone 39<br>36077 Altavilla Vicentina (Vicenza)<br>Italy<br>[phone]<br>[phone] |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Mr Boschi Alessandro<br>[phone]<br>[e-mail] |
| The common name of the device | Diode laser |
| Trade name / Propietary names | Doctor Smile A-810, B-980 Lasers |
| Classification name | Laser surgical instrument for use in general and plastic surgery and<br>dermatology |
| Product code | Gex |
| CFR Number | 21 CFR §878.4810 |
| Predicate Devices | Doctor Smile A-810, B-980:Lasers<br>- Arc Laser GmbH Fox Q-810, Q-980 K073322<br>- Biolase Ezlase® K082938<br>- Sirona Sirolaser K053161<br>- Kavo Gentleray 980 K072262<br>- Ceralas 980 K072779<br>- Claros Nano Dental Laser System K081652 |
| Product description | Doctor Smile A-810, B-980 Lasers are the same standard diode<br>medical lasers respectively with 810, 980 nm wavelength. |
| Intended Use | Doctor Smile A-810 Laser is intended for use in the following<br>procedure: Soft Tissue, Laser Periodontal procedures and tooth<br>whitening. Intra- and extra oral surgery including incision, excision,<br>vaporization, ablation, haemostasis and coagulation of oral soft<br>tissues, Laser soft tissue curettage, whitening.<br>Doctor Smile Diode B-980 Laser is intended for use in the following<br>procedure: Surgical applications requiring the ablation, vaporization,<br>excision, incision, haemostasis, or coagulation of soft tissue in<br>medical specialties including dentistry, dermatology, general surgery,<br>gynecology, ophthalmology, pulmonology, otolaryngology, othopedics. |

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| Performance standards | The Doctor Smile A-810, B-980 Lasers comply with the following<br>standards:<br>IEC 60601-1:1998+A1:1991+A2:1995<br>IEC 60601-2-22:1995<br>IEC 60825-1:1993+A1:1997+A2:2001<br>21 CFR 1040.10 and 1040.11 |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device technological<br>characteristics and<br>Comparison to Predicate<br>device(s) | Doctor Smile A-810, B-980 Lasers are portable instruments which<br>transmit laser energy via a contact fiber optic delivery system and<br>each unit is compromised of the following main components:<br>-a laser system console (including display panel, software and<br>control);<br>-a fiber optic delivery system;<br>-one or more handpieces<br>-protective eye ware<br>Doctor Smile Diode A-810, B-980 Lasers have the same intended use<br>and the same or substantially equivalent technical specifications and<br>mechanism of action as compared with the named predicated devices. |
| Conclusion: | The Doctor Smile A-810, B-980 Lasers have identical or similar<br>indications for use, principles of operation, overall technical and<br>functional capabilities. Therefore is substantially equivalent to the<br>predicate devices. They have similar intended uses and comply with<br>the same safety and performance standards. |

**Review:**
Boschi Alessandro

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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-like figure, composed of three curved lines that suggest wings and a head. The bird is oriented to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 0-8 2009

Lambda Scientifica S.p.A % Mr. Boschi Alessandro Via Retrone 39 36077 Altavilla Vicentina Italy

Re: K091562

Trade/Device Name: Doctor Smile A-810 B-980 Lasers 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: September 1, 2009 Received: September 1, 2009

Dear Mr. Alessandro:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Boschi Alessandro

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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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Image /page/4/Picture/1 description: The image shows the logo for LAMBDA Scientifica SpA. The logo consists of a lambda symbol inside of a circle on the left. To the right of the symbol is the text "LAMBDA Scientifica SpA". There is a line underneath the text.

## Indications for Use

510(k) Number (if known):

Device name: Doctor Smile A-810, B-980 Lasers

#### Doctor Smile A-810 Laser is intended for use in the following procedure:

Soft Tissue, Laser Periodontal procedures and tooth whitening Intra- and extra oral surgery including incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening.

Following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivoplasty, Gingival incision and excision

Haemostasis and coagulation, Implant recovery, Incision and drainage of abscess

Leukoplakia, Operculectorny, Oral papillectornies, Pulpotomy as an adjunct to root canal therary, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket. Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingiyal index, gingival bleeding index, probe depth, attachment loss and tooth mobility.). Light activation of whitening/bleaching material.

### Doctor Smile B-980 Laser is intended for use in the following procedure:

Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissue in medical specialties including dentistry, gastroenterology, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics.

#### Dental applications:

Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivoplasty, Gingivolasty, Gingival Troughing, Crown Lengthening, Haemostasis 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. Papillectory, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials

Prescription use

and/or

Over-the-counter use

(21 CFR 801 Subpart D)
Neil R. Sigh for xxx

Division of Surgical, Orthopedic, and Restorative Devices

(21 CFR 807 Subpart C)

**Review:**
Boschi Alessandro

ensori e Sistemi di Monitoraggio / Monitoring Systems and sensors 510(k) Numbe a Retrone n. 39 - 36077 Altavilla Vicentina (VI) Italia - Tel/fax [phone] /349954 http://www.lambdascientifica.com - E-Mail: [e-mail] Cap. Soc. Euro 500.000,00 - C.F. e P. I.V.A. 02558810244 - Registro Imprese di Vicenza n. 199230/96

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