(87 days)
Not Found
No
The summary describes a laser system for tattoo and lesion removal and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for removal of tattoos and lesions, which are medical treatments, classifying it as a therapeutic device.
No
The device is marketed for removal of tattoos and lesions, which are treatment indications, not diagnostic ones.
No
The device description explicitly states it is a "laser system" capable of emitting a pulsed treatment laser beam, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of tattoos and various lesions. This is a therapeutic application, directly treating the patient's body.
- Device Description: The device is a laser system that emits a pulsed laser beam. This is a physical treatment modality, not a diagnostic test performed on samples outside the 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 condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically alter tissue for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Schwartz Electro-Optics, Inc. CrystaLase 755 DP will be indicated for removal of tattoos of various types and colors, as well as epidermal, pigmented and vascular lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicate d lasers. No new indications were sought in this premarket notification and no clinical data was presented.
Product codes
GEX
Device Description
The Schwartz Electro-Optics, Inc. CrystaLase 755 DP System is a medical device which is capable of emitting a pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No new indications were sought in this premarket notification and no clinical data was presented.
Key Metrics
Not Found
Predicate Device(s)
Cynosure, Inc. PhotoGenica LPIR (K971737), Candela Corp. AlexLazz (K950831)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAY 2 2 1998
Image /page/0/Picture/1 description: The image shows the logo for SEO Medical. The logo is in black and white, with the letters "SEO" in a bold, blocky font. The word "Medical" is in a more traditional font and is placed to the right of "SEO". The logo is simple and professional, and it is likely used to identify a medical practice or organization.
3414 N. Orange Blossom Trail . Orla
510(k) Summary of Safety and Effectiveness The Schwartz Electro-Optics, Inc. CrystaLase 755 DP
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon the substantial equivalence determination is based.
The safety and effectiveness of the Schwartz Electro-Optics, Inc. CrystaLase 755 DP is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the following: Cynosure, Inc. PhotoGenica LPIR; Candela Corporation AlexLazz.
-
Company: Schwartz Electro-Optics, Inc. I. 3404 North Orange Blossom Trail Orlando, FL 32804
Schwartz Electro-Optics, inc. CrystaLase 755 DP II. Model: -
Cynosure, Inc. PhotoGenica LPIR (K971737), Candela Corp. AlexLazz (K950831) III. Predicate Devices:
-
The Schwartz Electro-Optics, Inc. CrystaLase 755 DP System is a medical device IV. Description: which is capable of emitting a pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
-
The Schwartz Electro-Optics, Inc. CrystaLase 755 DP will be indicated for removal V. Indications of tattoos of various types and colors, as well as epidermal, pigmented and vascular for Use: lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicate d lasers. No new indications were sought in this premarket notification and no clinical data was presented.
-
VI. Summary: From a design and clinical perspective, the predicate and candidate laser devices are of the same technology and have the same intended use. Based upon an anlaysis of the overall performance characteristics for the devices, Schwartz Electro-Optics, Inc. believes that no significant differences exist. Therefore, the Schwartz Electro-Optics, Inc. CrystaLase 755 DP should not raise any concerns regarding its overall safety and/or effectiveness.
-
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
MAY 22 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthew Assenmacher ·Director of the Solid State Laser Division Scwartz Electro-Optics, Incorporated 3404 North Orange Blossom Trail Orlando, Florida 32804
Re : K980710 CrystaLase 755 DP Trade Name: Requlatory Class: II Product Code: GEX Dated: February 24, 1998 Received: February 24, 1998
Dear Mr. Assenmacher:
We have reviewed your Section 510 (k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical -- Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices 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. Assenmacher
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
3
of
510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________ K980710
CrystaLase 755 DP DEVICE NAME:
INDICATIONS FOR USE:
The Schwartz Electro-Optics, Inc. CrystaLase 755 DP will be indicated for removal of tattoos of various types and colors, as well as epidermal, pigmented and vascular 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 755 DP laser system.
(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)
(Division Sign-Off)
Division of General Restorative Devices