(90 days)
ESC EpiLight® Hair Removal System, ESC PhotoDerm® HR
Not Found
No
The 510(k) summary describes an Intense Pulsed Light (IPL) system for hair removal and does not mention any AI or ML capabilities. The performance study focuses on clinical effectiveness and adverse effects, not on algorithmic performance.
No
The device is used for the removal of unwanted hair, which is generally considered a cosmetic procedure rather than a therapeutic one aimed at treating a disease or medical condition.
No
The Intended Use/Indications for Use states that the device is "used for the removal of unwanted hair," which is a treatment function, not a diagnostic one.
No
The device is described as an "Intense Pulsed Light System," which is a hardware-based technology for hair removal. The summary mentions clinical studies on the effectiveness of "IPLTM devices," further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted hair from all skin types." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not involve analyzing such specimens.
The description clearly indicates a device used for a physical treatment on the patient, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
Removal of unwanted hair in patients with skin type VI
ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.
Product codes
GEX
Device Description
Not Found
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
A multi-center study was conducted to examine the clinical effectiveness of IPLTM devices in the removal of unwanted her. The study documented the clearance rate and the adverse effects obtained when treating skin type VI patients using an IPLTM device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multi-center study was conducted to examine the clinical effectiveness of IPLTM devices in the removal of unwanted her. The study documented the clearance rate and the adverse effects obtained when treating skin type VI patients using an IPLTM device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ESC EpiLight® Hair Removal System, ESC PhotoDerm® HR
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
994014
FEB 2 4 2000
510(K) PREMARKET NOTIFICATION
Hair removal for skin type VI patients
ESC Medical Systems Ltd.
..............................................................................................................................................................................
510(K) Summary
| Submitter: | ESC Medical Systems Ltd.
Yokneam Industrial Park
Yokneam,20692, Israel
Phone: 972-4-959-9000 Fax: 972-4-959-9050 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Zvi Ladin, VP, Clinical Applications and Regulatory Affairs
ESC Inc.
250 First Avenue
Needham, MA 02495
Phone: 781-444-8446 Fax: 781-444-8812 |
| Date summary prepared: | November 23, 1999 |
| Device Trade Name: | IPLTM Device for hair removal |
| Common name: | EpiLight®; MultiLightTM |
| Classification name: | Laser instrument, powered, surgical (class II medical device) |
| Equivalent Devices: | ESC EpiLight® Hair Removal System
ESC PhotoDerm® HR |
| Clinical Information: | A multi-center study was conducted to examine the clinical effectiveness of
IPLTM devices in the removal of unwanted her. The study documented the
clearance rate and the adverse effects obtained when treating skin type VI patients
using an IPLTM device. |
| Intended Use: | Removal of unwanted hair in patients with skin type VI |
| Conclusion: | IPLTM devices used to treat skin type VI patients are substantially equivalent in
their level of safety and effectiveness to that obtained when using the same
devices to treat patients with skin types I - V |
| Additional Information: | None requested at this time |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2000
Dr. Zvi Ladin Corporate Vice President Clinical and Regulatory Affairs ESC Medical Systems Ltd. 250 First Avenue, Suite 300 Needham. Massachusetts 02494
Re: K994014 Trade Name: EpiLight and MultiLight™ Regulatory Class: II Product Code: GEX Dated: November 24, 1999 Received: November 26, 1999
Dear Dr. Ladin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Dr. Zvi Ladin
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Numill Vayen
& James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™
Indications For Use:
ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
---|---|---|
(Division Sign-Off) | ||
Division of General Restorative Devices | ||
510(k) Number | K994014 | |
Prescription Use | OR | Over-The-Counter Use |
(Per 21 CFR 801.109 |
(Optional Format 1-2-96)