(88 days)
Not Found
No
The document describes a light-based system and a cooling accessory, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is intended for permanent hair reduction, treatment of vascular lesions, and treatment of pigmented lesions, all of which address medical conditions or modify the body for health-related purposes. The CoolRoller™ also reduces thermal injury and pain.
No
The device is described as treating conditions like unwanted hair, vascular lesions, and pigmented lesions, which are therapeutic applications, not diagnostic ones. Its purpose is to perform procedures, not to identify or characterize diseases or conditions.
No
The device description clearly states it is a "light-based medical device" and mentions an accessory, the "CoolRoller™", both of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- EsteLux™ and CoolRoller™ Function: The EsteLux™ and CoolRoller™ system works by applying light and cooling directly to the skin for therapeutic purposes (hair reduction, treatment of vascular and pigmented lesions). This is a direct treatment applied to the body, not a test performed on a sample taken from the body.
The description clearly indicates a device used for direct treatment and physical effects on the skin, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EsteLux™ Pulsed Light system is intended to for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
The CoolRoller™ is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce pain and patient discomfort associated with light applications.
Product codes
GEX
Device Description
The EsteLux™ is a light-based medical device designed for permanent hair reduction, effective removal of unwanted hair, treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I-VI). The CoolRoller™ is an accessory providing pre-cooling of the skin, reduction in thermal injury, and reduction in pain and patient discomfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light-based
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
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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 EsteLux™ and CoolRoller™, and the predicate devices do not result in different performance or raise new questions of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Attachment 6
K020453 i/2
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the Palomar EsteLux™ Pulsed I ins Jro(x) 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: | February 6, 2002 |
| Device Trade Name: | Palomar EsteLux™ |
| and CoolRoller™ | |
| Common Name: | EsteLux™, CoolRoller™ |
| 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: | ESC IPL Quantum HR: K991935 |
Laserscope CoolSpot™; K984110
System Description:
The EsteLux™ is a light-based medical device designed for permanent hair reduction, effective removal of unwanted hair, treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I-VI). The CoolRoller™ is an accessory providing pre-cooling of the skin, reduction in thermal injury, and reduction in pain and patient discomfort.
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K020453 2/2
Intended Use of the Device:
The EsteLux™ System is intended for permanent hair reduction, effective removal of unwanted hair, treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I~VI). The Cool Roller™ is an accessory providing pre-cooling of the skin and increased patient comfort.
Performance Data:
The differences in the specifications of the EsteLux™ and CoolRoller™, and the predicate devices do not result in different performance or raise new questions of safety or efficacy.
Conclusion:
Based on the foregoing, the EsteLux™ System and the CoolRoller™ are substantially equivalent to the legally-marketed claimed predicate devices, i.e., the ESC IPLTM Quantum HR and Laserscope CoolSpot™, respectively.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2002
Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, NC 27511
Re: K020453
Trade/Device Name: EsteLux™ Pulsed Light System and CoolRoller™ Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 8, 2002 Received: February 11, 2002
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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
For 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
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INDICATIONS FOR USE STATEMENT
510(K) Number:
EsteLuxTM Device Name:
Indications for Use:
The EsteLux™ Pulsed Light system is intended to for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
The CoolRoller™ is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce pain and patient discomfort associated with light applications.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ర్క Prescription Use
OR Over-the-Counter Use (per 21 CFR 801.109)
Mùriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020453
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