(88 days)
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No
The document describes a laser device for tattoo and lesion removal and makes no mention of AI or ML technology.
Yes
The device is indicated for medical procedures such as the removal of tattoos and pigmented lesions, which falls under therapeutic uses.
No
The device is indicated for removal of tattoos and pigmented lesions, which is a treatment rather than a diagnostic purpose.
No
The device description explicitly mentions "laser energy" and "laser mediums," indicating a hardware component that delivers energy for treatment.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of tattoos and epidermal/pigmented lesions. This is a therapeutic/surgical application, not a diagnostic one.
- Device Description: The device is a laser system that delivers energy to tissue. This is consistent with a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to treat conditions directly on the body.
N/A
Intended Use / Indications for Use
The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented lesions.
Product codes
GEX
Device Description
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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
Prescription Use (Per 21 CFR 801.109)
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
K973603
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SCHWARTZ ELECTRO-OPTICS, Inc. CRYSTALASE 1064/532
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. and electronically. Schwartz Electro-Optics, Inc. believes that the mechanically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers. The Continuum Biomedical Medlite and the DermaLase have the ability to deliver laser energy at wavelengths of 1064 nm (Nd:YAG) and frequency doubled Nd:YAG at 532 nm (Green).
In regards to safety or effectiveness of the Schwartz Electro-Optics, Inc. CrystaLase 1064/532, Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns.
- This information was prepared for the sole purpose of compliance with the Advisory: 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.
Prescription Use
(Per 21 CFR 801.109)
IX.
(Division Sign-Off)
Division of General Restorative Device
510(k) Number
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 19 1997
Mr. Timothy J. Shea Director Schwartz Electro-Optics. Incorporated 3404 N. Orange Blossom Trail Orlando, Florida 32804
Re: K973603 Trade Name: CrystaLase 1064/532 Laser System Regulatory Class: II Product Code: GEX Dated: September 2, 1997 Received: September 22, 1997
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.
fciellaf
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
g7 X603
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SCHWARTZ ELECTRO-OPTICS, INC.
September 30, 1997
DEC 1 9 1997
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850
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Indications for Use Schwartz Electro-Optics, Inc. CrystaLase 1064/532
The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 1064/532.