(318 days)
Cynosure Apogee Laser
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No
The summary describes a laser device for hair reduction and vascular lesion removal, focusing on its technical specifications (power, pulse width) and intended use. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices. The description is purely about the physical operation and application of the laser.
No
The device is indicated for cosmetic procedures (hair removal) and vascular lesion removal, which are not typically considered therapeutic.
No
The device is indicated for therapeutic purposes (vascular lesion removal and hair reduction), not for diagnosing medical conditions.
No
The device description clearly outlines hardware components (power supply, water cooling/heating system, optical bench) and describes energy delivery, indicating it is a physical laser device, not software only.
Based on the provided information, the Cynosure Apogee-TKS laser is not an IVD (In Vitro Diagnostic) device.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Cynosure Apogee-TKS Function: The description clearly states the device is a laser used for vascular lesion removal and hair reduction. This is a therapeutic and aesthetic treatment performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the Cynosure Apogee-TKS laser falls under the category of a therapeutic or aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cynosure Apogee-TKS Iaser is indicated for vascular lesion removal and stable, long-term, or permanent hair reduction.
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs re-growing after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4-12 months oomploto growth of ermanent hair reduction does not necessarily imply the elimination of all hairs in the treated area.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Apogee-TKS Laser consists of three interconnected sections: the power supply, the water cooling and heating system and the optical bench. The device is capable of delivering 60 J/cm² at 5, 10, 20 or 40 milliseconds pulse width.
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
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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)
Non-clinical 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.
Cynosure Apogee Laser
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.
0
| JUN 2 9 2000 | K942717 |
|---|---|
| 501(K) summary | |
| Submitter | Cynosure, Inc. |
| 10 Elizabeth Drive | |
| Chelmsford, MA 01824 | |
| Contact: | George Cho |
| Senior Vice President, Medical Technology | |
| Date Summary Prepared: | August 12, 1999 |
| Device Trade Name: | Apogee-TKS Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser |
| 79-GEX | |
| 21 CFR 878.48 | |
| Equivalent Device: | Cynosure Apogee Laser |
| Device Description: | The Apogee-TKS Laser consists of three |
| interconnected sections: the power supply, the | |
| water cooling and heating system and the | |
| optical bench. The device is capable of | |
| delivering 60 J/cm² at 5, 10, 20 or 40 | |
| milliseconds pulse width. | |
| Intended Use: | For stable, long-term, or permanent hair |
| reduction. | |
| Comparison: | The Apogee-TKS Laser is substantially |
| equivalent to the Cynosure Apogee Laser in | |
| terms of treatment wavelength, pulse duration, | |
| pulse energy and biological effects. | |
| Non-clinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Apogee-TKS Laser is another safe and |
| effective way for permanent hair reduction. | |
| Additional Information: | None requested at this time. |
.
1
Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The logo is simple and uses a black-and-white color scheme.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2000
Mr. George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K992757
Trade Name: Cynosure Apogee-TKS Dermatological Laser Regulatory Class: II Product Code: GEX Dated: May 25, 2000 Received: May 26, 2000
Dear Mr. Cho:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 provial 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for 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) 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 and additionally 809.10 for in vitro 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Nesseli Voya
Soccelia M. Witten, Ph.D., M.D. 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)
Device Name:
Cynosure Apogee-TKS Dermatological Laser for Permanent Hair Epilation
Indication for Use:
ation for oos.
The Cynosure Apogee-TKS Iaser is indicated for vascular lesion removal and stable, long-term, or permanent hair reduction.
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs re-growing after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4-12 months oomploto growth of ermanent hair reduction does not necessarily imply the elimination of all hairs in the treated area.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K990757 | |
| Prescription Use | ||
| (Per21 CFR 801.109) | OR | Over-the-Counter Use |