(77 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on light-based treatment.
Yes
The device is intended for the treatment of inflammatory acne, which is a medical condition.
No
The device description states it is "designed for treatment of inflammatory acne" and the summary of performance studies supports "safety and efficacy." There is no mention of diagnosis or diagnostic capabilities.
No
The device description explicitly states it is a "light-based medical device" and includes a "handpiece accessory," indicating it is a hardware device that emits light for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of inflammatory acne (acne vulgaris)". This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "light-based medical device designed for treatment of inflammatory acne". Again, this points to a therapeutic function.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are specifically designed to perform tests on these types of samples to aid in diagnosis, monitoring, or screening.
Therefore, the LuxV™ handpiece is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EsteLuxTM System with the LuxVTM handpiece is intended for the treatment of inflammatory acne (acne vulgaris).
Product codes
GEX
Device Description
The EsteLux Pulsed Light System with the LuxVTM handpiece accessory is a light-based medical device designed for treatment of inflammatory acne.
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
clinical data was provided to support the safety and efficacy of the LuxV handpiece.
Key Metrics
Not Found
Predicate Device(s)
ClearTouch by Radiancy
Reference Device(s)
Candela Smoothbeam, Laserscope Aura, ICN Photonics NLite
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
Attachment 5
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the LuxVM handpiece is submitted in accordance with the requirements of Safe Medical Device Act (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 | |
| 781-993-2300 | |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | January 12, 2004 |
| Device Trade Name: | Palomar LuxVTTM Handpiece |
| Common Name: | LuxVTTM |
| 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: | ClearTouch by Radiancy; Candela Smoothbeam; |
| Laserscope Aura; ICN Photonics NLite | |
| System Description: | The EsteLux Pulsed Light System with the LuxVTTM |
| handpiece accessory is a light-based medical device | |
| designed for treatment of inflammatory acne. | |
| Intended Use of the Device: | The EsteLuxTM System with the LuxVTTM handpiece |
| is intended for the treatment of inflammatory acne | |
| (acne vulgaris). |
1
Performance Data:
The differences in the specifications of the EsteLux LuxVIM and the ClearTouch do not result in different performance or raise new questions of safety or efficacy. In addition, clinical data was provided to support the safety and efficacy of the LuxV handpiece.
Conclusion:
Based on the foregoing, the LuxVTM handpiece is substantially equivalent to the legally marketed claimed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2004
Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Technologies, Inc. 131 Kelekent Lane Cary, North Carolina 27511
Re: K040081 Trade/Device Name: LuxVTM 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, 2004 Received: January 15, 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. 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 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) 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 Office of Compliance at (301) 594-4659. 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/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
4
INDICATIONS FOR USE STATEMENT
X 040081 510(K) Number:
LuxVIM Device Name:
Indications for Use:
The LuxV™ handpiece is intended for the treatment of inflammatory acne (acne vulgaris).
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
✓
OR Over-the-Counter Use (per 21 CFR 801.109)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
8040081 510(k) Number_