(318 days)
The Cynosure Apogee-TKS laser 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. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area.
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.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary and an FDA clearance letter for the Cynosure Apogee-TKS Laser, indicating its substantial equivalence to a predicate device.
Key Findings from the Documents:
- No Clinical Performance Data: The 510(k) summary explicitly states "Clinical Performance Data: None" and "Non-clinical Performance Data: None."
- Substantial Equivalence: The FDA clearance is based on the device being "substantially equivalent" to the Cynosure Apogee Laser in terms of "treatment wavelength, pulse duration, pulse energy and biological effects." This implies that the device is deemed safe and effective because its characteristics are similar to an already cleared device, not necessarily through a new study demonstrating pre-defined acceptance criteria for the new device itself.
- Intended Use/Indication for Use: The device is indicated for "stable, long-term, or permanent hair reduction." Permanent hair reduction is further 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. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area." This is the definition of the desired outcome, but not a quantifiable acceptance criterion with a specific threshold that the new device had to meet through a study.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance via substantial equivalence rather than a detailed performance study with acceptance criteria.
{0}------------------------------------------------
| JUN 2 9 2000 | K942717 |
|---|---|
| 501(K) summary | |
| Submitter | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
| Contact: | George ChoSenior 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, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Cynosure Apogee Laser |
| Device Description: | The Apogee-TKS Laser consists of threeinterconnected sections: the power supply, thewater cooling and heating system and theoptical bench. The device is capable ofdelivering 60 J/cm² at 5, 10, 20 or 40milliseconds pulse width. |
| Intended Use: | For stable, long-term, or permanent hairreduction. |
| Comparison: | The Apogee-TKS Laser is substantiallyequivalent to the Cynosure Apogee Laser interms 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 andeffective 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 |
§ 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.