(103 days)
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 Unemupted 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
Doctor Smile A-810, B-980 Lasers are the same standard diode medical lasers respectively with 810, 980 nm wavelength. Doctor Smile A-810, B-980 Lasers are portable instruments which transmit laser energy via a contact fiber optic delivery system and each unit is compromised of the following main components: -a laser system console (including display panel, software and control); -a fiber optic delivery system; -one or more handpieces -protective eye ware
This document is a 510(k) Summary for the Doctor Smile A-810 and B-980 Lasers. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and performance data in the context of an AI/medical device.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance studies typically conducted for novel devices or AI-powered diagnostics.
However, I can provide the following based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria for clinical performance (e.g., sensitivity, specificity) or report device performance in that manner. Instead, it states compliance with general device standards and substantial equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (No clinical performance criteria are stated in this 510(k) summary) | Not applicable (No clinical performance data is reported in this 510(k) summary) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a test set of patient data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment activity is described for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document is for a laser surgical instrument, without any AI component or human-in-the-loop performance described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth for clinical performance is described. The "ground truth" in this context is the safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not applicable. This refers to a laser device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device-Specific Information from the document:
This 510(k) submission establishes substantial equivalence of the Doctor Smile A-810 and B-980 Lasers to predicate devices, based on:
- Identical or similar indications for use.
- Similar principles of operation.
- Overall technical and functional capabilities.
- Compliance with the same safety and performance standards:
- IEC 60601-1:1998+A1:1991+A2:1995
- IEC 60601-2-22:1995
- IEC 60825-1:1993+A1:1997+A2:2001
- 21 CFR 1040.10 and 1040.11
The document highlights the device's technological characteristics and compares them to predicate devices, noting that the Doctor Smile A-810, B-980 Lasers are portable instruments that transmit laser energy via a contact fiber optic delivery system, consisting of a laser system console, fiber optic delivery system, handpieces, and protective eyewear.
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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.Via Retrone 3936077 Altavilla Vicentina (Vicenza)Italy+39 0444 349 165+39 0444 349 954 |
|---|---|
| Contact person | Mr Boschi Alessandro+39 0444 349 165boschi@lambdascientifica.com |
| 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 anddermatology |
| Product code | Gex |
| CFR Number | 21 CFR §878.4810 |
| Predicate Devices | Doctor Smile A-810, B-980:Lasers- 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 |
| Product description | Doctor Smile A-810, B-980 Lasers are the same standard diodemedical lasers respectively with 810, 980 nm wavelength. |
| Intended Use | Doctor Smile A-810 Laser is intended for use in the followingprocedure: Soft Tissue, Laser Periodontal procedures and toothwhitening. Intra- and extra oral surgery including incision, excision,vaporization, ablation, haemostasis and coagulation of oral softtissues, Laser soft tissue curettage, whitening.Doctor Smile Diode B-980 Laser is intended for use in the followingprocedure: Surgical applications requiring the ablation, vaporization,excision, incision, haemostasis, or coagulation of soft tissue inmedical specialties including dentistry, dermatology, general surgery,gynecology, ophthalmology, pulmonology, otolaryngology, othopedics. |
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| Performance standards | The Doctor Smile A-810, B-980 Lasers comply with the followingstandards:IEC 60601-1:1998+A1:1991+A2:1995IEC 60601-2-22:1995IEC 60825-1:1993+A1:1997+A2:200121 CFR 1040.10 and 1040.11 |
|---|---|
| Device technologicalcharacteristics andComparison to Predicatedevice(s) | Doctor Smile A-810, B-980 Lasers are portable instruments whichtransmit laser energy via a contact fiber optic delivery system andeach unit is compromised of the following main components:-a laser system console (including display panel, software andcontrol);-a fiber optic delivery system;-one or more handpieces-protective eye wareDoctor Smile Diode A-810, B-980 Lasers have the same intended useand the same or substantially equivalent technical specifications andmechanism of action as compared with the named predicated devices. |
| Conclusion: | The Doctor Smile A-810, B-980 Lasers have identical or similarindications for use, principles of operation, overall technical andfunctional capabilities. Therefore is substantially equivalent to thepredicate devices. They have similar intended uses and comply withthe same safety and performance standards. |
Review:
Boschi Alessandro
7
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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 (800) 638-2041 or (240) 276-3150 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 +39-0444-349165 /349954 http://www.lambdascientifica.com - E-Mail: info@lambdascientifica.com Cap. Soc. Euro 500.000,00 - C.F. e P. I.V.A. 02558810244 - Registro Imprese di Vicenza n. 199230/96
5
§ 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.