(88 days)
The Powerlite 600® EP System is used for the removal of unwanted hair.
The Powerlite 600® EP System delivers pulsed light at a wavelength beginning at a wavelength of 600nm. The device consists of three interconnected sections: the system console which houses the internal cooling system, power supply and micro-controller, the handle hose to the handpiece, and the handpiece, which houses the wavequide.
The provided text is a 510(k) summary for the Powerlite 600® EP System. It does not contain details about acceptance criteria, device performance, clinical studies showing the device meets acceptance criteria, or ground truth establishment.
The document explicitly states:
- "8. Discussion of Clinical Tests Performed: Non-Applicable"
This indicates that the submission did not rely on clinical trials to demonstrate substantial equivalence. Instead, it focused on the device's technical similarity and intended use compared to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from the provided text. The document's purpose is to establish substantial equivalence based on non-clinical aspects and comparison to a predicate device, not to report on clinical performance against specific acceptance criteria.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
Submitter's Identification: 1.
Preswede AB Humleqatan 15 501 10 Boras, Sweden
Date Summary Prepared: February 6, 2003
2. Name of the Device:
Powerlite 600® EP System.
Predicate Device Information: 3.
K#963249, Epilight™ Hair Removal System, ESC Medical Systems, Yokneam Industrial Park, Yokneam 20692, ISRAEL.
4. Device Description:
The Powerlite 600® EP System delivers pulsed light at a wavelength beginning at a wavelength of 600nm. The device consists of three interconnected sections: the system console which houses the internal cooling system, power supply and micro-controller, the handle hose to the handpiece, and the handpiece, which houses the wavequide.
5. Intended Use:
The Powerlite 600® EP System is used for the removal of unwanted hair.
6. Comparison to Predicate Devices:
The Powerlite 600® EP and the Epilight devices are very similar or identical in terms of the device structure and its technology. Both systems are electrooptical medical devices designed for effective photothermal treatment of unwanted hair and its removal. Both devices deliver intense pulsed light, broad spectrum light, starting from 590nm or 600nm, with sufficient energy to be absorbed in the hair follicles and penetrate deeply enough and at a temperature high enough to denature and impair hair growth without damaging surrounding skin.
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A main difference between Powerlite 600® EP and Epilight devices is the type of control terminal. The Powerlite 600® EP System is LCD touch panel controlled, while the Epilight system is terminal -controlled.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Electrical and EMC testing per IEC 60601-1 and IEC 60601-1-2 requirements
8. Discussion of Clinical Tests Performed:
Non-Applicable
9. Conclusions:
The Powerlite 600® EP System has the same intended use and similar characteristics as the Epilight™ Hair Removal System. Moreover, documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Powerlite 600® EP System is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2003
Preswede AB c/o Ms. Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K030423 Trade/Device Name: Powerlite 600® EP System 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: February 6, 2003 Received: February 10, 2003
Dear Ms. Goldstein-Falk:
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.
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Page 2 - Ms. Susan Goldstein-Falk
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 Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia 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
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Exhibit B
Page 1
510(k) Number (if known):
Device Name: Powerlite 600® EP System
Indications For Use:
The Powerlite 600® EP System is used for the removal of unwanted hair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Muriam C Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO3CY2 510(k) Number ................................................................................................................................................................
§ 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.