(91 days)
Not Found
No
The summary describes a laser handpiece and its intended uses for tattoo and lesion removal. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for medical procedures such as tattoo removal and removal of various pigmented lesions, which serve a therapeutic purpose.
No
The device is a laser handpiece indicated for tattoo removal and removal of pigmented lesions, which are therapeutic rather than diagnostic applications.
No
The device description clearly states it is a laser handpiece, which is a hardware component that produces and delivers laser energy. It is an accessory to a larger system that includes a console, cooling system, and power supply, all of which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The description clearly states that the Palomar QYAG Laser Handpiece delivers laser energy directly to the tissue. This is a therapeutic or cosmetic treatment applied to the body, not a diagnostic test performed on a sample from the body.
- Intended Use: The intended uses listed are all related to treating conditions on the skin (tattoo removal, removal of pigmented lesions). These are procedures performed on the patient's body.
Therefore, the Palomar QYAG Laser Handpiece is a therapeutic or cosmetic laser device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark (i.e. dark blue or black) ink tattoo removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The QYAG Laser handpiece is an accessory to the Palomar ICON System, which is composed of a system console, cooling system, power supply and handpiece. Laser energy is produced in the handpiece and delivered directly to the tissue.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061436, K083899, K123168, K113588
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
3 2013 MAY
510(k) Summary QYAG Laser Handpiece
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
Palomar Medical Technologies, Inc. NAME:
15 Network Drive ADDRESS: Burlington, MA 01803 Phone: (781) 993-2348 Fax: (781) 993-2330
CONTACT: Nicole Brown Regulatory Affairs Specialist II
DATE PREPARED: January 21, 2013
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: | Palomar QYAG Laser Handpiece | |
|---|---|---|
| COMMON/USUAL NAME: | Q: SWITCHED : Nd:YAG laser | |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and | |
| plastic surgery and in dermatology. | ||
| (21 CFR §878.4810) |
GEX PRODUCT CODE:
3. PREDICATE DEVICES
Palomar Medical Technologies, Inc. PALOMAR Q-YAG 5 ND: YAG LASER SYSTEM K061436
HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System
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K083899
Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM K123168
Lutronic Corporation Spectra Laser System K113588
4. INTENDED USE
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions ( e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.
5. DEVICE DESCRIPTION
The QYAG Laser handpiece is an accessory to the Palomar ICON System, which is composed of a system console, cooling system, power supply and handpiece. Laser energy is produced in the handpiece and delivered directly to the tissue.
6. PERFORMANCE DATA
The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information.
SUBSTANTIAL EQUIVALENCE 7.
The QYAG Laser Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the QYAG Laser also shares the same technological characteristics as its predicates.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 3, 2013
Palomar Medical Technologies, Inc. % Ms. Nicole Brown Regulatory Affairs Specialist II 15 Network Drive Burlington, Massachusetts 01803
Re: K130250
Trade/Device Name: Palomar QYAG Laser Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: March 01. 2013
Received: March 04, 2013
Dear Ms. Brown:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Nicole Brown
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, For
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130250
Device Name: QYAG Laser System
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal, removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (- e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.
Prescription Use X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21-CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden
2013.05.08 15:49:47 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number K130250