(303 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical and technical specifications of a CO2 laser.
Yes
The device is used for incision, excision, ablation, vaporization, and coagulation of body soft tissue, which are procedures that directly treat a medical condition.
No
The device is a CO2 laser used for incision, excision, ablation, vaporization, and coagulation of body soft tissue. These are therapeutic actions, not diagnostic ones.
No
The device description clearly indicates it is a physical CO2 laser system with specific dimensions, weight, and electrical requirements, not a software-only 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 incision, excision, coagulation, ablation, and vaporization of body soft tissue. These are procedures performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. This device does not perform such analysis on specimens.
- Device Description: The description details a surgical laser system, not a device for analyzing biological samples.
Therefore, the Affirm CO2 and Affirm CO2 HP lasers are therapeutic devices used for surgical procedures, not IVDs.
N/A
Intended Use / Indications for Use
The Affirm CO2 and Affirm CO2 HP lasers are indicated for incision, excision, and coagulation of body soft tissue.
The Affirm CO2 and Affirm CO2 HP lasers with SmartScan scanner are indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissue 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
GEX
Device Description
Affirm CO2 and Affirm CO2 HP lasers are CO2 laser, having CO2 gas as the lasing medium. It is a laser with a wavelength of 10.6 µm. 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 tissue, intraoral tissues, skin
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 (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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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)
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
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.
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K,081424
| Submitter: | Cynosure, Inc.
5 Carlisle Road
Westford, MA 01886 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | May 16, 2008 |
| Device Trade Name: | Affirm CO2 and Affirm CO2 HP lasers |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.4810 |
| Equivalent Device: | Smart CO2 laser and SmartXide CO2 with DOT Scanner laser |
| Device Description: | Affirm CO2 and Affirm CO2 HP lasers are CO2 laser, having CO2 gas
as the lasing medium. It is a laser with a wavelength of 10.6 µm.
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: | Affirm CO2 and Affirm CO2 HP lasers are indicated for incision,
excision, and coagulation of body soft tissue. |
| Comparison: | The Affirm CO2 and Affirm CO2 HP lasers are substantially equivalent
to the Smart CO2 laser and the SmartXide CO2 with DOT Scanner
laser, with the same principle of operation, the same wavelength and
essentially the same power range as the predicate devices for the same
indications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Affirm CO2 and Affirm CO2 HP lasers are another safe and
effective device for body soft tissue applications. |
| Additional Information: | none |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cynosure, Inc. % Mr. George Cho Senior Vice President of Medical Technology 5 Carlisle Road Westford, Massachusetts 01886
MAR 1 9 2009
Re: K081424
Trade/Device Name: Affirm CO2 and Affirm CO2 HP lassers 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: March 13, 2009 Received: March 16, 2009
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 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 - Mr. George Cho
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA indiver of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device on regally
to proceed to the market 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 Surveyes arverse arverse 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.
Sincerely yours,
Mark M Millam
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): 1 08 | 424
Device Name: Affirm CO2 and Affirm CO2 HP lasers
Indications For Use:
The Affirm CO2 and Affirm CO2 HP lasers with SmartScan scanner are indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissue 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 X OR (Part 21 CFR 801 Subpart D)
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 Device Evaluation (ODE)
Mitchel forman
Division of General, Restorative, and Neurological Devices
510(k) Number K081424