(141 days)
The Schwartz Electro-Optics, Inc. CrystaLase 755 is indicated for removal of tattoos of various types and colors and benign epidermal pigmented lesions.
Not Found
This 510(k) submission (K973867 for the Schwartz Electro-Optics, Inc. CrystaLase 755) does not contain the information needed to answer your request about acceptance criteria and a study proving the device meets those criteria.
The provided documents are a 510(k) summary and the FDA's clearance letter. These documents are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study data against specific acceptance criteria.
Here's why the information is missing:
- 510(k) Summary: This document states that "from a technology perspective, theory of operation of all the aforementioned devices are all the same" and "Schwartz Electro-Optics, Inc. believes that the technological characteristics of the CrystaLase 755 are similar to the predicate lasers." It also states "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns." This language indicates a reliance on the predicate device's established safety and effectiveness rather than new, extensive performance studies for the CrystaLase 755 itself.
- FDA Clearance Letter: This letter confirms the device is "substantially equivalent" to predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and it does not necessarily require new clinical or performance data if technological characteristics are similar and do not raise new questions of safety or effectiveness.
Therefore, I cannot fill out the requested table or answer the specific questions about the study details for this particular submission.
This type of information (acceptance criteria, detailed study design, sample sizes, ground truth establishment, etc.) would typically be found in direct performance studies, clinical trial reports, or more detailed sections of a 510(k) submission if the device presented novel technology or significant differences from its predicate. As this submission relies on substantial equivalence and similarity to predicate devices, such detailed a study is not provided here.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IX. SCHWARTZ ELECTRO-OPTICS, Inc. CRYSTALASE 755
FEB 1 0 1998
From a technology perspective, theory of operation of all the aforementioned devices are While the laser mediums are identical, all the systems are similar both all the same. mechanically and electronically. Schwartz Electro-Optics, Inc. believes that the technological characteristics of the CrystaLase 755 are similar to the predicate lasers.
In regards to safety or effectiveness of the Schwartz Electro-Optics, Inc. CrystaLase 755, Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns.
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Timothy J. Shea Director of the Solid State Laser Division Schwartz Electro-Optics, Incorporated 3404 North Orange Blossom Trail Orlando, Florida 32804
FEB 1 0 1998
Re: K973867
Trade Name: Schwartz Electro-Optics, Inc. CrystaLase 755 Laser System Regulatory Class: II Product Code: GEX Dated: January 6, 1998 Received: January 6, 1998
Dear Mr. Shea:
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 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 (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 requirements , 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
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Page 2 - Mr. Shea
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
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
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510(k) Number (If known):
510(k) Number (If known): K 973867
Device Name: Schwartz Electro-Optics, Inc. CrystaLase 755
Indications for Use: The Schwartz Electro-Optics, Inc. CrystaLase 755 is indicated for removal of tattoos of various types and colors and benign epidermal pigmented lesions.
(Please Do Not Write Below This Line - Continue on Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Or
(Division Sign-Off)
Division of General Restorative Devices
510k) Number K473867
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.