(154 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or training/test sets for algorithms. The device description focuses on light-based photothermal treatment.
Yes
The "Intended Use / Indications for Use" states that the device is for "removal of unwanted body and/or facial hair," and the "Device Description" states it is a "light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment." These descriptions indicate it performs a physical treatment for a specific condition (unwanted hair), which is characteristic of a therapeutic device.
No
The device is described as being for "removal of unwanted body and/or facial hair" and utilizes "selective photothermal treatment," which is a therapeutic intervention, not a diagnostic one. Its purpose is to treat a condition (unwanted hair) rather than to identify or characterize one.
No
The device description explicitly states it is a "light-based medical device," indicating it includes hardware components for generating and delivering light, not just software.
Based on the provided information, the DeLight™ II HR System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the removal of unwanted body and/or facial hair in adults. This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The device is described as a light-based medical device for selective photothermal treatment. This involves applying energy to the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro).
The DeLight™ II HR System operates on the body to achieve a physical effect (hair removal), which is the opposite of how an IVD functions.
N/A
Intended Use / Indications for Use
The DeLight™ II HR System is a light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment. The device is speciffically indicated for dermatological use.
The DeLight™ II HR System is intended for removal of unwanted body and/or facial hair in adults.
The System is specifically indicated for dermatological use by physicians and healthcare professionals.
Product codes
GEX
Device Description
The DeLight™ II HR System is a light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light-based
Anatomical Site
Body and/or facial hair
Indicated Patient Age Range
adults
Intended User / Care Setting
physicians and healthcare professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The DeLight™ II HR System has been studied in an IRB approved human clinical trial, in which various skin types and various hair colors were treated by the DeLight™ II HR System. Clearance rates and occurrence of side effects were examined. The data was compared to published data on the clearance and side effects of the predicate device. The clinical results and the comparison to the predicate device demonstrate that the DeLight™ II HR System is safe and effective. Thus, the DeLight™ II HR System is substantially equivalent to the predicate device.
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.
0
K992482
510(k) Summary
Radiancy (Israel) Ltd.'s DeLight™ II HR System
| Submitter's name: | Radiancy (Israel) Ltd. |
|---|---|
| Submitter's address: | Lev Hatamar Building |
| 4 Pekeris St., | |
| Rabin Science Based Industrial Park | |
| Rehovot 76702 | |
| ISRAEL | |
| Telephone: | +972-8-9477374 |
| Fax: | +972-8-9477373 |
| Contact Person: | Simona Konkol, Director of Regulatory Affairs. |
| Preparation Date: | July 22, 1999 |
| Device Trade Name: | DeLight™ II HR System |
| Common Name: | Light Based Hair Removal System |
| Classification Name: | Laser Surgical Instrument pursuant to 21 CFR 878.4810 |
Predicate Device:
EpiLight® Hair Removal System, manufactured by ESC Medical Systems Ltd. of Yokneam, Israel, 510(k) #K963249.
Description of the Device:
The DeLight™ II HR System is a light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment.
Intended Use:
The DeLight™ II HR System is a light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment. The device is speciffically indicated for dermatological use.
1
Comparison of Technological Characteristic:
Radiancy has performed a detailed side-by-side comparison of the technical specification of the predicate device and the DeLight™ II HR System. The results have shown that the system specifications of the DeLight™ II HR System are substantially equivalent to the technical specifications of the cleared EpiLight® System. The DeLight™ II HR System has few differences from the predicate device, for example, the DeLight™ II HR operates at lower fluence levels than the predicate device and uses one pulse light while the predicate device uses multiple pulses with variable pulse width. The predicate device is computer controlled while the DeLight™ II HR System is controlled manually by the user. However, these minor differences do not raise new questions of safety or efficacy, thus the DeLight™ II HR System is substantially equivalent to its predicate device.
Clinical Performance Data:
The DeLight™ II HR System has been studied in an IRB approved human clinical trial, in which various skin types and various hair colors were treated by the DeLight™ II HR System. Clearance rates and occurrence of side effects were examined. The data was compared to published data on the clearance and side effects of the predicate device. The clinical results and the comparison to the predicate device demonstrate that the DeLight™ II HR System is safe and effective. Thus, the DeLight™ II HR System is substantially equivalent to the predicate device.
Non-Clinical Performance Data: None required.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 27 1999
Radiancy Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Re: K992482 Trade Name: DeLight II HR System Regulatory Class: II Product Code: GEX Dated: December 1, 1999 Received: December 1, 1999
Dear Mr. Kahan:
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 (OS) 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.
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Page 2 - Mr. Jonathan S. Kahan
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,
Nessel/Sager
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
15992482 510 (k) Number:_____ New Submission
Device Name: ______ DeLight™ II HR System_____________________________________________________________________________________________________________________________________
Indications for use:
The DeLight™ II HR System is intended for removal of unwanted body and/or facial hair in adults.
The System is specifically indicated for dermatological use by physicians and healthcare professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Russell Sage for Trp
(Division Sign-Off) Division of General Restora 51U(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use -------