(238 days)
Not Found
No
The device description and intended use are purely focused on the laser technology and its application for various dermatological treatments. There is no mention of AI, ML, image processing, or any data-driven decision-making within the device's operation.
No.
The device is indicated for aesthetic procedures such as tattoo and hair removal, and treatment of vascular and pigmented lesions, which are not typically considered therapeutic in the context of treating diseases or medical conditions.
No
The device description and intended use indicate it is an Nd:YAG laser system for therapeutic purposes like tattoo removal, hair removal, and treatment of vascular/pigmented lesions, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a power supply unit, footswitch, umbilical cord, and handpiece containing the laser. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic device used for treating various skin conditions (tattoo removal, hair removal, vascular lesions, pigmented lesions) by applying laser energy directly to the patient's body.
- Device Description: The description details a laser system with a handpiece that is held against the treatment area. This is consistent with a therapeutic device, not a device that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
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 directly treat conditions on the body.
N/A
Intended Use / Indications for Use
- At the 1064 nm wavelength dark ink tattoo removal of pigmented lesions . and the removal or lightening of hair.
- and the Femoval of ifgifteding of help of red ink tattoos, treatment of vascular hesions . including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)
Product codes (comma separated list FDA assigned to the subject device)
79-GEX
Device Description
The UltraLight II Nd:YAG 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 bandpiece. 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.
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
None
Description of the test set, sample size, data source, and annotation protocol
None
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None
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.
K003460, K970808, K983054, K011677
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
Attachment I 510(K) Summary DEC 1 4 2004 UltraLight II Nd: YAG Laser System
This 510(K) Summary of safety and effectiveness for the UltraLight II Nd:YAG 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: | Sandstone Medical Technologies, LLC |
|---|---|
| Address: | Sandstone Medical Technologies LLC |
| 516 Scott Street | |
| Homewood, AL 35209 USA | |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 1-205-290-8251- Phone |
| Preparation Date: | April 15, 2004 |
| Device Trade Name: | UltraLight II Nd:YAG Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | Clear Light ™ Nd:Yag Laser K003460 |
| Medlite Laser System K970808, K983054 and K011677 |
Description of the UltraLight II Nd:YAG Laser System:
Image /page/0/Picture/5 description: The image contains a handwritten word, "and", in a cursive style. The word is slightly tilted, with the "a" and "n" connected and the "d" extending upwards with a loop. The writing appears to be in black ink on a white background.
Intended use of the UltraLight II Nd: Y AG Laser System:
Performance Data: Results of Clinical Study:
Conclusion:
The UltraLight II Nd:YAG 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 bandpiece. 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
substantially The UltraLight II Nd:YAG laser system is equivalent to other existing Nd:YAG Laser Systems in commercial distribution for use in Dermatology and Plastic Surgery.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three diagonal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Sandstone Medical Technologies, LLC c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776
Re: K041011
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: October 28, 2004 Received: November 3, 2004
Dear Ms. Hoy:
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. Connie White Hoy
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with cation. The FDA finding of substantial equivalence of your device to a legally prerketed 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 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 Macer Sacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K Pending 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
KO41011 / SCO2
Sandstone Medical Technologies UltraLight II Nd:YAG Device Name:
Laser System
Indications For Use:
- At the 1064 nm wavelength dark ink tattoo removal of pigmented lesions . and the removal or lightening of hair.
- and the Femoval of ifgifteding of help of red ink tattoos, treatment of vascular hesions . including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
AND/OR
Prescription Use XX (Part 21 CFR 801 Subpart D) 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 Evaluation (ODE)
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