(141 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use of a laser for tattoo and lesion removal.
Yes
The device is indicated for the removal of tattoos and benign epidermal pigmented lesions, which are medical treatments.
No
The device is indicated for removal of tattoos and benign epidermal pigmented lesions, which is a treatment function, not a diagnostic one.
No
The provided 510(k) summary describes a laser device ("Schwartz Electro-Optics, Inc. CrystaLase 755") which is a hardware-based medical device used for tattoo and lesion removal. There is no indication of it being a software-only device.
Based on the provided information, the Schwartz Electro-Optics, Inc. CrystaLase 755 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of tattoos and benign epidermal pigmented lesions. This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens.
Therefore, the device described is a laser used for dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
1
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)