(166 days)
- At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions . and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)
The UltraLight II Nd: Y AG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the handpiece. In standard use, the handpiece is held against the treatment area dn the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.
The provided text describes the UltraLight II Nd:YAG Laser System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria. The "Performance Data: Results of Clinical Study:" section explicitly states "None," indicating that no clinical study was performed or submitted to support this 510(k) submission.
Therefore, I cannot provide the requested information, and the following table and details will be left blank or indicated as "Not provided in the input."
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the input | Not provided in the input |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided in the input (no test set mentioned).
- Data Provenance: Not provided in the input (no test set mentioned).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided in the input (no test set mentioned).
- Qualifications of Experts: Not provided in the input (no test set mentioned).
4. Adjudication method for the test set:
- Adjudication Method: Not provided in the input (no test set mentioned).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No.
- Effect Size: Not applicable (no MRMC study mentioned, and the device is a laser system, not an AI assistance tool for human readers).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: No. The device is a laser system, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable (no performance study was conducted or presented in this document).
8. The sample size for the training set:
- Sample Size: Not applicable (no training set mentioned, as no performance study was conducted or presented).
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable (no training set mentioned).
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Attachment I Special 510(K) Summary UltraLight II Nd: Y AG Laser System
082407
FEB - 3 2009
This 510(K) Summary of safety and effectiveness for the UltraLight II Nd:Y AG Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
Applicant:
Address:
Sandstone Medical Technologies, LLC
Sandstone Medical Technologies LLC 516 Scott Street Homewood, AL 35209 USA
Mr. Mark Rohrer
1-205-290-8251- Phone
August 20, 2008
UltraLight II Nd: YAG Laser System
Nd:YAG Laser System
Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48
UltraLight II Nd:YAG Laser System K041011
The UltraLight II Nd: Y AG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the handpiece. In standard use, the handpiece is held against the treatment area dn the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.
At the 1064 nm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
At the 532 nm wavelength - removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasis, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)
None None
The UltraLight II Nd:YAG laser system is substantially equivalent to other existing Nd:YAG Laser Systems in commercial distribution for use in Dermatology and Plastic Surgery.
Contact Person:
Telephone:
Preparation Date:
Device Trade Name:
Common Name:
Classification Name:
Legally Marketed Predicate Device:
Description of the UltraLight II Nd:YAG Laser System:
Intended use of the UltraLight II Nd: Y AG Laser System:
:
Performance Data: Results of Clinical Study:
Conclusion:
ri
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, represented by a series of curved lines and shapes. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Homewood, Alabama 35209
FEB - 3 2009
Re: K082407
Trade/Device Name: Sandstone Medical Technologies UltraLight II 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: January 13, 2009 Received: January 14, 2009
Dear Mr. Rohrer:
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. Iisting 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
{2}------------------------------------------------
Page 2 – Mr. Mark Rohrer
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.
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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
68240
510(k) Number (if known): K Pending
Device Name:
Sandstone Medical Technologies UltraLight II Nd:YAG
Laser System
Indications For Use:
- At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions . and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions � including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Ballaton (ODE) Division of General, Restorative,
and Neurological Devices
Page 1 of 1 08240 510(k) Number
§ 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.