(253 days)
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No
The document describes a laser device for surgical and dental applications and does not mention any AI or ML components or capabilities.
Yes
The device is intended for various surgical and dental procedures such as incision, excision, vaporization, and coagulation of soft tissue, which directly address a health condition or restore function.
No
The device is described as a surgical laser used for incision/excision, vaporization, ablation, and coagulation of soft tissue, which are therapeutic functions. It does not mention any diagnostic capabilities like analyzing biological signals or images to identify disease or conditions.
No
The device description explicitly states it is a "980 nm wavelength diode laser," which is a hardware component, not software.
No, 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 stLase™ is a surgical laser used for direct interaction with soft tissue (incision, excision, vaporization, etc.). It is a therapeutic and surgical device, not a device that analyzes specimens outside the body.
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's tissue, not the analysis of samples.
Therefore, based on the provided information, the stLase™ is a surgical laser device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The stLase™ with surgical laser operation that can be used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and
The stLase™ with dental laser operation that can be used in contact or non-contact technique is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: 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 diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
Product codes
GEX
Device Description
The Dental Photonics stLase™ is a 980 nm wavelength diode laser intended for use in general surgical applications and dental laser applications.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue, intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Substantial equivalence of the stLase™ is demonstrated by similarity in technical specifications to the predicate devices. As a laser device, the stLase™ complies with 21 CFR 1040.10 and 1040.11 and other applicable laser and electrical safety standards.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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pg 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
GENERAL INFORMATION
SEP 1 0 2010
| Trade Name | stLase™ |
|---|---|
| Classification Name | LASER INSTRUMENT, SURGICAL, POWERED |
| Class | II |
| Product Code | GEX |
| CFR section | 878.4810 |
| Device panel | General & Plastic Surgery |
| Legally marketed | |
| predicate devices | K081015: Biolitec Ceralas D980 |
| K072262: KaVo GENTLEray 980 | |
| K982629: Dornier Medilase D Laser | |
| Submitter/ | |
| Contacts | Marcy Moore |
| MMP Medical Associates, LLC | |
| 16 Appleton St. | |
| Waltham, MA 02453 | |
| Phone: 919-363-2432 | |
| Fax: 919-363-0085 |
DEVICE DESCRIPTION
The Dental Photonics stLase™ is a 980 nm wavelength diode laser intended for use in general surgical applications and dental laser applications.
INTENDED USE
The stLase™ with surgical laser operation that can be used in contact or non-contact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coaqulation of soft tissue, and
The stLase™ with dental laser operation that can be used in contact or non-contact technique is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: 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 diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure ന് unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment
1
of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket}, pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
PERFORMANCE DATA
ﺮ ﻣ
Substantial equivalence of the stLase™ is demonstrated by similarity in technical specifications to the predicate devices. As a laser device, the stLase™ complies with 21 CFR 1040.10 and 1040.11 and other applicable laser and electrical safety standards.
SUBSTANTIAL EQUIVALENCE
The stLase™ has the same intended use, material design and function as predicate devices for dental laser applications: Biolitec Ceralas D980 family of lasers K081015; the Kavo GentleRay 980, K072262; and the same intended use, material design and function as the predicate device for general surgery laser applications: Dornier Medilas D family of lasers, K982629.
SUMMARY PREPARATION DATE: 8/23/2010
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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 with three wing-like extensions. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dental Photonics, Inc. % MMP Medical Associates, LLC Ms. Marcy Moore 16 Appleton Street Waltham, Massachusetts 02453
Re: K094049
SEP 1 0 2010
Trade/Device Name: stLase™ 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: August 24, 2010 Received: August 25, 2010
Dear Ms. Moore:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Ms. Marcy Moore
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 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Dec mall
Dec or
Mark N Aelkersc Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: K094049
Device Name: stLase™
K 094049
SEP 1 0 2010
Indications for Use:
The stLase™ with surgical laser operation that can be used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and
The stLase™ with dental laser operation that can be used in contact or non-contact technique is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: 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 diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
| Prescription Use 👍(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|
| ----------------------------------------------- | -------- | --------------------------------------------- |
Neltebyder
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K094049 |
|---|---|
| --------------- | ---------------- |