(185 days)
Not Found
No
The provided text does not mention AI, ML, or any related concepts like neural networks, training data, or performance metrics typically associated with AI/ML devices. The description focuses on the device's light-based technology and its intended uses for various dermatological conditions.
Yes
The device is indicated for various medical treatments, including the removal of pigmented lesions, treatment of vascular lesions, reduction of scars, and coagulation and hemostasis of soft tissue, all of which are considered therapeutic applications.
No
The device is indicated for various treatments (hair removal, lesion treatment, tattoo removal, etc.), but not for diagnosing medical conditions. It performs therapeutic functions rather than diagnostic ones.
No
The device description explicitly states it consists of a "base unit and handpiece attachments," indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the Lux1064TM handpiece is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Lux1064TM Intended Use: The intended uses listed for the Lux1064TM handpiece are all related to direct treatment of the human body using light energy. These include hair removal, treatment of skin lesions, tattoos, vascular lesions, scars, wrinkles, and pseudofolliculitis barbae.
- Device Description: The device is described as a "light-based medical device" with a base unit and handpiece attachments, consistent with a device that applies energy to the body.
- Lack of IVD Indicators: There is no mention of collecting or analyzing biological specimens, diagnostic purposes based on specimen analysis, or any of the typical components or processes associated with IVD devices.
Therefore, the Lux1064TM handpiece is a therapeutic medical device that applies light energy to the body for various treatments, not an IVD device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Lux1064TM handpiece is indicated for:
- The removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction.
- The treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, caféau-lait macules, and plaques.
- Verrucae, skin tags, seborrheic keratosis,
- Tattoos (significant reduction in the intensity of black and/or blue-black tattoos).
- The Lux1064™ is indicated for pigmented lessons to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments.
- The treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, Venus lake, facial and leg veins.
- The Lux10641M is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Coagulation and hemostasis of soft tissue.
- Treatment of wrinkles.
- Pseudofolliculitis barbae (PFB)
Product codes
GEX
Device Description
The Lux1064™ is a versatile, light-based medical device consisting of a base unit and handpiece attachments.
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
Prescription Use (per 21 CFR 801.109)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The differences in the specifications of the Lux1064™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy.
Based on the foregoing, the Lux1064™ System is substantially equivalent to the legally-marketed claimed predicate devices, i.e., the Lumenis IPL/NdYAG, Candela GentleYAG, and Laserscope Lyra series.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
StarLux™ Pulsed Light System (handpieces), Lumenis Family of IPL & IPL/NdYAG, Candela Gentle YAG, Laserscope LIRA
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
K041879 1/2
JAN 13 2005
Attachment 4
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the Palomar StarLux™ Pulsed Light This JTV(K) Sullimary of Safety and Enterty, and Enternets of Safe Medical Device Act
System is submitted in accordance with the requirements of Safe Medical Device Act System is submitted in accordance with the requestion (ODE) guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Palomar Medical Technologies, Inc. |
|---|---|
| Address: | 82 Cambridge St. |
| Burlington, MA 01803 | |
| 781-993-2300 | |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | July 8, 2004 |
| Device Trade Name: | Palomar Lux1064™ NdYAG Handpiece |
| Common Name: | Lux1064™ |
| Classification Name: | Laser surgical instrument for use in General and |
| Plastic Surgery and in Dermatology | |
| (see: 21 CFR 878-4810). | |
| Product Code: GEX | |
| Panel: 79 | |
| Legally-Marketed Predicate Device: | StarLux™ Pulsed Light System (handpieces) |
| Lumenis Family of IPL & IPL/NdYAG, Candela | |
| Gentle YAG, Laserscope LIRA | |
| System Description: | The Lux1064™ is a versatile, light-based medical |
| device consisting of a base unit and handpiece | |
| attachments. | |
| Intended Use of the Device: | The Lux1064™ is a light-based medical device |
| designed for effective removal of unwanted hair, | |
| permanent hair reduction, PFB, treatment of wrinkles | |
| and the treatment of vascular and pigmented lesions. |
1
K041879 2/2
Performance Data:
Conclusion:
The differences in the specifications of the Lux1064™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy.
Based on the foregoing, the Lux1064™ System is substantially equivalent to the legally-marketed claimed predicate devices, i.e., the Lumenis IPL/NdYAG, Candela GentleYAG, and Laserscope Lyra series.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles three overlapping human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2005
Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, North Carolina 27511
Re: K041879
Trade/Device Name: Palomar Lux1064™ Nd: YAG Handpiece 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 22, 2004 Received: October 25, 2004
Dear Ms. Moore:
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.
3
Page 2 – Ms. Marcy Moore
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Muriam 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
4
INDICATIONS FOR USE STATEMENT
510(K) Number:
Device Name: Palomar Lux 1064TM Nd: Y AG Handpiece
Indications for Use:
The Lux1064TM handpiece is indicated for:
- The removal of unwanted hair for skin types I-VI, and to effect . stable long-term permanent hair reduction.
- The treatment of benign pigmented lesions such as, but not t limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, caféau-lait macules, and plaques.
- . Verrucae, skin tags, seborrheic keratosis,
- Tattoos (significant reduction in the intensity of black and/or 속 blue-black tattoos).
- The Lux1064™ is indicated for pigmented lessons to reduce . lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments.
- The treatment of vascular lesions such as but not limited to, . port wine stains, hemangiomas, telangiectasias, rosacea, Venus lake, facial and leg veins.
- The Lux10641M is also indicated for the reduction of red ◆ pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Coagulation and hemostasis of soft tissue. ●
- ♥ Treatment of wrinkles.
- Pseudofolliculitis barbae (PFB) ●
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam' ( Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_4/4/877