(10 days)
Lumenis OpusDent Family laser, Millennium Dental Technologies PerioLase Dental Laser
Not Found
No
The summary describes a standard CO2 laser device and its intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
Yes
The device is indicated for various surgical and aesthetic applications, as well as specific periodontal applications, all of which aim to treat medical conditions or restore bodily function, aligning with the definition of a therapeutic device.
No
The device is indicated for surgical applications such as incision, ablation, vaporization, and coagulation of body soft tissues, as well as periodontal applications, which are therapeutic interventions rather than diagnostic procedures.
No
The device description explicitly states it is a CO2 laser with a sealed CO2 gas tube, a physical component, and provides its weight and dimensions, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical laser for the incision, ablation, vaporization, and coagulation of body soft tissues. These are all procedures performed directly on the patient's body.
- Device Description: The device description details a CO2 laser with a specific wavelength and physical characteristics, consistent with a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical procedures.
N/A
Intended Use / Indications for Use
The Smart CO2 laser is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues. It is also indicated for laser assisted new attachment procedure.
The Smart US 20 D / UltraSpeed and Smart Clinic laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialities of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic liaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
Also, the Smart CO2 surgical laser is indicated for periodontal applications such as, but not limited to: Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), Biopsies, Frenectomy, Frenum release, Gingivoplasty, Papillectomy, Vestibuloplasty, Hyperplasia, Operculectomy, Drainage (abscess), Flap surgery, Fibroma (nonmalignant tumor, mucosa, tongue), Epulis, Aphthous ulcers, Removal of soft tissue, cysts, and tumors, Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
The PerioPulse laser is indicated for the removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement). It is also indicated for laser assisted new attachment procedure (cementum-medlated periodontal ligment new attachment to the root surface in the absence of long junctional epithelium)
Product codes
79-GEX, GEX
Device Description
Smart CO2 is a CO2 laser, having a sealed CO2 gas tube as the lasing medium. It is a laser with a wavelength of 10.6 um. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues including intraoral tissues, periodontal pocket
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
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
Not Found
Predicate Device(s)
Lumenis OpusDent Family laser, Millennium Dental Technologies PerioLase Dental Laser
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
510(K) Summary
MAY - 5 2008 Cynosure, Inc. Submitter: 5 Carlisle Road Westford, MA 01886 Contact: George Cho Senior Vice President of Medical Technology Date Summary Prepared: April 24, 2008 Device Trade Name: Smart CO2 Common Name: Medical Laser System Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810 Equivalent Device: Lumenis OpusDent Family laser and Millennium Dental Technologies PerioLase Dental Laser Device Description: Smart CO2 is a CO2 laser, having a sealed CO2 gas tube as the lasing medium. It is a laser with a wavelength of 10.6 um. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. Intended Use: The Smart CO2 laser is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues. It is also indicated for laser assisted new attachment procedure. Comparison: The Smart CO2 laser is substantially equivalent to the predicate devices. Thet have the same principle of operation and essentially the same power range and the same indications for uses. Nonclinical Performance Data: none Clinical Performance Data: none Conclusion: The Smart CO2 laser is another safe and effective device for body soft tissue, including intraoral soft tissue applications. Additional Information: none
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2008
Cynosure, Inc. % Mr. George Cho Sr. VP, Medical Technology 5 Carlisle Road Westford, Massachusetts 01886
Re: K081181 Trade/Device Name: Smart CO2 ((Smart US 20 D / UltraSpeed, Smart Clinic and PerioPulse) Laser 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: April 24, 2008 Received: April 25, 2008
Dear Mr. Cho:
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
2
Page 2 - Mr. George Cho
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Milken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K081181
Device Name: Smart CO2 ((Smart US 20 D / UltraSpeed, Smart Clinic and PerioPulse) Laser
Indications For Use:
The Smart US 20 D / UltraSpeed and Smart Clinic laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialities of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology,
endoscopic liaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
Also, the Smart CO2 surgical laser is indicated for periodontal applications such as, but not limited to:
Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular A
debridement)
Biopsies A
Frenectomy, Frenum release
Gingivoplasty
Papillectomy
ﺮ Vestibuloplasty
ア Hyperplasia
♪ Operculectomy
ア Drainage (abscess)
Flap surgery
Fibroma (nonmalignant tumor, mucosa, tongue)
Epulis
Aphthous ulcers
Removal of soft tissue, cysts, and tumors >
Laser assisted new attachment procedure (cementum-mediated periodontal ligament > new-attachment to the root surface in the absence of long junctional epithelium).
The PerioPulse laser is indicated for the removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement). It is also indicated for laser assisted new attachment procedure (cementum-medlated periodontal ligment new attachment to the root surface in the absence of long junctional epithelium)
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Defice Evaluation (ODE)
Nek
Crossion Sign-Off Dision of General, Restorative, and Neurological Devices
510(k) Number K041141