(21 days)
Not Found
Not Found
No
The summary describes a laser device for tissue manipulation and does not mention any AI or ML components or functionalities.
Yes
The device is used for skin resurfacing, and the incision, excision, ablation, or vaporization of soft bodily tissues, which are therapeutic interventions.
No.
The device's intended use is for skin resurfacing and the incision, excision, ablation, or vaporization of soft bodily tissues, which are therapeutic and surgical procedures, not diagnostic ones. It does not mention analyzing or identifying conditions.
No
The device description explicitly states it consists of hardware components: a power supply, water cooling system, and optical bench.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues." These are all procedures performed on the body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description details a laser system with a power supply, cooling system, and optical bench. This aligns with a surgical or therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and modify bodily tissues.
N/A
Intended Use / Indications for Use
The Cynosure SureScan with the CO3 Er:YAG Laser is used for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues.
Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.
Product codes (comma separated list FDA assigned to the subject device)
79-GEX
Device Description
The SureScan with the CO3 Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft bodily tissues
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): 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.
Not Found
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.
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
| Submitter: | Cynosure, Inc.
10 Elizabeth drive
Chelmsford, MA 01824 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | June 18, 1999 |
| Device Trade name: | Cynosure SureScan with the CO3 Er:YAG Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device | Cynosure CO3 Er:YAG Laser |
| Device description: | The SureScan with the CO3 Er:YAG Laser
consists of three interconnected sections: the
power supply, the water cooling system and the
optical bench. |
| Intended Use: | Skin resurfacing and for the incision, excision
ablation or vaporization of soft bodily tissues. |
| Comparison: | The SureScan with the CO3 Er:YAG Laser is
substantially equivalent to the Cynosure CO3
Er:YAG Laser in terms of treatment wavelength,
pulse duration, pulse energy, and biological
effects. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cynosure SureScan with the CO3 Er:YAG
Laser is another safe and effective laser for skin
resurfacing and for the incision, excision, ablation
or vaporization of soft bodily tissues. |
| Additional Information: | None requested at this time. |
1
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 1999
Mr. George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive 10 Limsford, Massachusetts 01824
K992084 K992084
Trade Name: Cynosure SureScan with the CO3 Er: YAG Laser
Trade Name: Cynosure SEV Re: Regulatory Class: GEX Product Code: II Dated: June 18, 1999 Received: June 21, 1999
Dear Mr. Cho:
1941 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 We have reviewed your Section 510(k) notification of manter and above and we have determined the devices markets in interstate commerce prior to use stated in the enclosure) to devices marketed in increasing to to devices that May 28, 1976, the enacment date of the Medical Device Finishaleral Food, Drug, and have been reclassified in accordance with the provisions of the general controls
Cosmetic Act (Act). You may, therefore, market the device, subject to the generals for Cosmetic Act (Act). You may, therefore, market the Act include requirements for
provisions of the Act. The general controls provisions of the Act include requirements for provisions of the Act. The general controls provisions of the Active, labeling, and
annual registration, listing of devices, good manufacturing practice, labeling, and annual registration, fisting of active, or active, and adulteration.
Prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n and the success of the chiest to such additional controls. Existing major If your device is classified (see above) into entrols. Existing major
(Premarket Approval), it may be subject to such additional controls. Existing major (Premarket Approval), it may be subject to such additions. The Code of Federal Regultions, Title 21.
regulations affecting your device can be found in the Code of Federal in regulations affecting your device can be found in the coon assumes compliance with the
Parts 800 to 895. A substantially equivalent determination assumes county System Parts 800 to 895. A substantially equirement, as set forth in the Quality System
current Good Manufacturing Practice requirement, as set forth in the Quality System current Good Manufacturing Practice requirences: Gencral regulation (21 CFR Part 820) and that,
Regulation (QS) for Medical Devices: Gencral regulation (21 CFR Parts of the Regulation (QS) for Medical Devices: Gentelar (viri tration (FDA) will verify
through periodic (QS) inspections, the Food and Drug Administration (FDA) in regulatory through periodic (QS) inspections, the Food and Drag result in regulation may result in regulatory such assumptions. Failure to comply with in Christ concerning your device in the action. In addition, FDA may publish turne and notification submission does
Federal Register. Please note: this response to your premarket notification of the Act for Federal Register. Please note: this response to your promations of the Act for
not affect any obligation you might have moder sections. Or other Federal law not affect any obligation you might have under sections 531 through 3 12 67 and 11
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. George Cho
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. "The PDA missification 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 If you desire speoffic acries its from diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. advertising of your do regulation entitled, "Misbranding by reference to prematiket notification" (21 CFR 807.97). Other general information on your responsibilities under the nonication (21 OF IC 0071) - 3 211-5 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page ol
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Cynosure SurcScan with the CO3 Er:YAG Laser
Indications For Use:
The Cynosure SureScan with the CO3 Er: YAG Laser is used for skin resurfacing, The Cynosure SureScan with the COS Et. ITTS Lace. In the Costs of bodily tissues.
and for the incision, excision, ablation or vaporization of soft bodily tissues.
Typical applications include dermatology, plastic surgery, urology, Typical applications include definatology, placio surgery, and of .
gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.
(PLEASE DO NOT WRITE BELOW TIJIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Ducts R992084
510(k) Number