(196 days)
The Palomar Q-YAG 5™ Nd: YAG laser system is indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation, dark ink tattoo removal (e.g.) black ink), removal of pigmented lesions, including, but not limited to, lentigines, nevi, melasma, and café-au-lait, and the removal or lightening of hair. The 532 mm way nevels gth is indicated for the removal of red ink tattoos, treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, portwine stains, and most pigmented lesions (e.g., lentigines, ephlides).
The 1064/532 nm blended wavelength is indicated for tattoo removal.
The complete system consists of a power supply unit, a cooling unit, a foot switch, and the handpiece that connects the laser unit and cooling unit using an umbilical cord. In standard use, the handpiece is held against the treatment area and the light pulse is delivered when the foot-switch is depressed. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
The provided 510(k) summary for the Palomar Q-YAG 5™ Nd:YAG Laser System does not contain details of a study with acceptance criteria and reported device performance in the typical format of a clinical or performance study for a machine learning or AI device.
Instead, the submission relies on the device's compliance with existing FDA performance standards for laser products and claims substantial equivalence to a legally marketed predicate device. This is a common pathway for medical devices that are not primarily software or AI-driven and do not introduce new fundamental technology or mechanisms of action.
Therefore, many of the specific details requested (like sample sizes for test sets, ground truth establishment for AI, MRMC studies, etc.) are not applicable or not provided in this type of submission.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Compliance with 21 CFR §1040.10 (Performance Standards for Laser Products) | The device complies with 21 CFR §1040.10. |
| Compliance with 21 CFR §1040.11 (Specific Purpose Laser Products – e.g., medical lasers) | The device complies with 21 CFR §1040.11. |
| Safety and Effectiveness substantially equivalent to predicate device (Continuum Electro-Optics, Inc. Medlite™ C3 Q-Switched:Nd:YAG Laser and Palomar Q-YAG 5™ Nd:YAG Laser System) | "The data presented in the 510(k) premarket notification support the safety and effectiveness of the device and do not raise new questions of safety or efficacy. Based on the foregoing, the Palomar Q-YAG 5™ Nd:YAG Laser System is substantially equivalent to its legally-marketed predicate devices." |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of a clinical performance study with discrete test sets. This 510(k) relies on compliance with laser product performance standards and a substantial equivalence claim, not a de novo clinical trial with a defined test set. The "data presented in the 510(k)" would likely refer to engineering and bench testing data to demonstrate compliance with the physical and electrical safety standards of laser devices, rather than data from a clinical test set for algorithmic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a ground truth established by experts for a test set, as this is not an AI or diagnostic interpretation device requiring such a process.
4. Adjudication method for the test set:
- Not applicable. No mention of a test set or adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is typically done for AI or diagnostic devices to show improved human performance with AI assistance. It is not relevant for a laser system like this.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used:
- Not applicable. The "ground truth" for this device's performance is its adherence to established laser safety standards (21 CFR §1040.10 & 1040.11) and the demonstrated equivalence of its physical and functional specifications to the predicate device.
8. The sample size for the training set:
- Not applicable. This device is a hardware laser system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or ground truth establishment in this context.
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K 061436
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the Q-YAG 5™ Nd:YAG Laser System is submitted in accordance with the requirements of Safe >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Palomar Medical Technologies, Inc. | ||
|---|---|---|---|
| Address: | 82 Cambridge St.Burlington, MA 01803 | DEC - 6 2006 | |
| Contact Person: | Sharon L. Timberlake | ||
| Telephone: | 781-993-2414 | ||
| Preparation Date: | 5-23-06 | ||
| Device Trade Name: | Palomar Q-YAG 5TM Nd:YAG Laser System | ||
| Common Name: | Q:Switched Nd:YAG | ||
| Classification Name: | Laser surgical instrument for use in General andPlastic Surgery and in Dermatology(see: 21 CFR 878.4810). | ||
| Product Code: | GEX | ||
| Legally-Marketed Predicate Device: | Continuum Electro-Optics, Inc. MedliteTM C3 Q-Switched:Nd:YAG LaserPalomar Q-YAG 5TM Nd:YAG Laser System | ||
| System Description: | The complete system consists of a power supplyunit, a cooling unit, a foot switch, and the handpiecethat connects the laser unit and cooling unit usingan umbilical cord. In standard use, the handpiece isheld against the treatment area and the light pulse isdelivered when the foot-switch is depressed. Laserparameters and other system features are controlledfrom a display panel located on the front of thepower supply unit. |
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The Palomar Q-YAG 5™ Nd:YAG laser system is Intended Use of the Device: indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation, dark ink tattoo removal (e.g., black ink), removal of pigmented lesions, including, but not limited to, lentigines, nevi, melasma, and café-au-lait, and the removal or lightening of hair. The 532 nm wavelength is indicated for the removal of red ink tattoos, treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, portwine stains, and most pigmented lesions (e.g., lentigines, ephlides). The 1064/532 nm blended wavelength is indicated for tattoo removal. The device complies with the following U.S. Food Performance Data: and Drug Administration performance standards: 21 CFR §1040.10 & 1040.11. The data presented in the 510(k) premarket notification support the safety and effectiveness of the device and do not raise new questions of safety or efficacy. Based on the foregoing, the Palomar Q-YAG 5 TM Conclusion: Nd:YAG Laser System is substantially equivalent to its legally-marketed predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
DEC = 6 2006
Re: K061436
Trade/Device Name: Q-YAG 5"" Nd:YAG laser system Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 10, 2006 Received: October 11, 2006
Dear Ms. Timberlake:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 - Ms. Sharon Timberlake, RAC, CCRA
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, permitts your levice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K 06 | 4 36
Device Name: Q-YAG 5™ Nd: YAG laser system
Indications for Use:
The Palomar Q-YAG 5™ Nd: YAG laser system is indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation, dark ink tattoo removal (e.g.) black ink), removal of pigmented lesions, including, but not limited to, lentigines, nevi, melasma, and café-au-lait, and the removal or lightening of hair. The 532 mm way nevels gth is indicated for the removal of red ink tattoos, treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, portwine stains, and most pigmented lesions (e.g., lentigines, ephlides).
The 1064/532 nm blended wavelength is indicated for tattoo removal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
| Over-The-Counter Use X | |
|---|---|
| -- | -------------------------- |
| 510(k) Number | K061436 |
|---|---|
| (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.