(143 days)
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No
The document describes a standard CO2 laser system and does not mention any AI or ML components, image processing, or performance studies related to algorithmic analysis.
Yes
The device is used for medical procedures involving incision, excision, ablation, vaporization, and coagulation of body soft tissues as described in the "Intended Use / Indications for Use" section.
No
The device's intended use is for incision, excision, ablation, vaporization, and coagulation of body soft tissues using a laser, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a CO2 laser with a physical weight and dimensions, electrical requirements, and a footswitch for activation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a CO2 laser used for surgical procedures on body soft tissues. It performs actions like incision, excision, ablation, vaporization, and coagulation. These are direct interventions on the body, not tests performed on samples outside the body.
- Intended Use: The intended use describes surgical applications in various medical specialties. It does not mention any diagnostic testing or analysis of biological samples.
Therefore, the Smart CO2 Lasers are therapeutic devices used for surgical procedures, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Smart CO2 Lasers are indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues. The use with the scanning unit is indicated for ablative skin resurfacing.
The smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Smart CO2 lasers (SmartXide, Smart US20D) are CO2 laser, having a sealed CO2 gas tube as the lasing medium. These are lasers with a wavelength of 10.6 um. Laser activation is by a footswitch. Overall weight of the laser is 30 kg, and the size is 120 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 15A, 50-60 Hz, single phase.
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
body soft tissues including intraoral tissues
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: None Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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510(K) Summary
2 7 2007 El En. S.p.A. Submitter: via Baldanzese, 17 50041 Calenzano (FI), Italy Andrea Tozzi Contact: Ouality System Manager & Official Correspondent July, 30, 2007 Date Summary Prepared: Smart CO2 (SmartXide, Smart US20D) with DOT scanner Device Trade Name: Medical Laser System Common Name: Instrument, surgical, powered, laser Classification Name: 79-GEX 21 CFR 878.4810 Equivalent Device: Lumenis UltraPulse Encore and delivery device accessories The Smart CO2 lasers (SmartXide, Smart US20D) are CO2 laser, Device Description: having a sealed CO2 gas tube as the lasing medium. These are lasers with a wavelength of 10.6 um. Laser activation is by a footswitch. Overall weight of the laser is 30 kg, and the size is 120 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 15A, 50-60 Hz, single phase. The Smart CO2 Lasers are indicated for incision, excision, Intended Use: ablation, vaporization and coagulation of body soft tissues including intraoral tissues. The use with the scanning unit is indicated for ablative skin resurfacing. The Smart CO2 Lasers are substantially equivalent to the Lumenis Comparison: UltraPulse Encore lasers and delivery device accessories . They are both CO2 lasers with a scanning unit as an accessory, for the identical indications for use. Nonclinical Performance Data: None Clinical Performance Data: None Conclusion: The Smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are two more safe and effective devices for incision, excision, ablation, vaporization and coagulation of body soft tissue, including intraoral tissue. Additional Information: None
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized eagle with three lines representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.
Public Health Service
DEC 2 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
El. En. Electronic Engineering S.p.A % Ms. Andrea Tozzi Ouality System Manager Via Baldanzese, 17 50041 Calenzano (FI), Italy
Re: K072159
Trade/Device Name: Smart CO2 (SmartXide, Smart US20D) Laser with DOT scanner 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: November 08, 2007 Received: November 13, 2007
Dear Ms. Tozzi:
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 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.
2
Page 2 - Ms. Andrea Tozzi
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 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 Millhusan
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): _K072/S9
Smart CO2 (SmartXide , Smart US20D) Laser with DOT scanner Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Prescriptive Use (Part 21 CFR 801 Subpart D)
OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bruchard
Division of General. Restorative. and Neurological Devices
510(k) Number K072159