(72 days)
Not Found
Not Found
No
The summary describes a phototherapeutic device for hair removal and dermatological conditions. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The changes described are related to hardware (light unit assembly) and expanded indications for use.
Yes
The device is intended to provide phototherapeutic light and treat dermatological conditions, specifically for hair removal, which are considered therapeutic actions.
No
The device is intended to provide phototherapeutic light and remove hair, which are treatment functions, not diagnostic ones.
No
The device description explicitly mentions a "light unit assembly," indicating a hardware component that delivers phototherapeutic light. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- SkinStation Function: The SkinStation is a phototherapeutic device that applies light directly to the body for treatment purposes (hair removal and dermatological conditions). It does not analyze samples taken from the body.
The description clearly indicates a device that interacts directly with the patient's skin, not a device that analyzes biological samples in a lab setting.
N/A
Intended Use / Indications for Use
The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for hair removal in Fitzpatrick Skin Types V and VI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial
Indicated Patient Age Range
Adults
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data demonstrates that the Radiancy SkinStation removes unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI with only minor side effects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
KOSI671
Radiancy (Israel) Ltd.'s Radiancy SkinStation® Photoepilation System with Modified Light Unit Assembly for Hair Removal
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Manufacturer: | Radiancy (Israel) Ltd.
9 Gan Rave Street
Industrial Park
Yavne
Israel |
|--------------------------|-----------------------------------------------------------------------------------|
| | |
| Telephone:
Facsimile: | +972-8-9438010
+972-8-9438020 |
| Contact Person: | Jonathan S. Kahan, Esq.
Regulatory Counsel
Hogan & Hartson L.L.P.
555 Thirteenth Street, N.W.
Washington, D.C. 20004-1109
Telephone: (202) 637-5794
Facsimile: (202) 637-5910
Email: JSKahan@HHLaw.com |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | June 22, 2005 |
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | Radiancy SkinStation with Modified LUA |
|---|---|
| Common Name: | Pulsed Light System and Light Unit Assembly |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery |
| and in dermatology (21 C.F.R. § 878.4810) |
| Manufacturing Facility: | Radiancy (Israel) Ltd. |
|---|---|
| 9 Gan Rave Street | |
| Industrial Park | |
| Yavne, Israel |
| Establishment | |
|---|---|
| Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |
1
Predicate Devices
Radiancy SkinStation Photoepilation Systems
AesThera Corporation, Model AIP
Medical Bio Care Sweden AB., ProLite
Palomar Medical Technologies, Inc., StarLux
Intended Use / Indications for Use
The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.
Technological Characteristics
The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for hair removal in Fitzpatrick Skin Types V and VI.
Substantial Equivalence
The Radiancy SkinStation, as modified, has the same intended use and very similar indications for use, principles of operation and technological characteristics as the cleared Radiancy SkinStation, and with the AesThera Corporation Model AIP, Medical Bio Care Sweden AB. ProLite, and the Palomar Medical Technologies, Inc., StarLux. The minor difference between the Radiancy SkinStation and the predicates do not raise new issues of safety and effectiveness. Clinical data demonstrates that the Radiancy SkinStation removes unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI with only minor side effects. Thus, the Radiancy SkinStation are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and entwined snakes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 0 2 2005
Radiancy (Israel) Ltd. c/o Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street Washington, D.C. 20004-1109
Re: K051671
Trade/Device Name: Radiancy Skin Station with Modified Light Unit Assembly 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: June 22, 2005 Received: June 22, 2005
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave ro rowed your 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 conniner to Has) 2018-11-19, 2018 11:15 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- Mr. Jonathan S. Kahan, Esq.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manisang of substantial equivalence of your device to a legally premaired 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 If you desire specific acrive int 3 %. (240) 276-0115. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Sincerely, yours,
Barbara Buchnd
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use Form
| 510(k) Number (if known): | K051671 |
|---|---|
| Device Name: | Radiancy SkinStation with Modified Light Unit Assembly |
| Indications for Use: |
The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.
Prescription Use _X
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 C F.R. 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aubare Preelunds for mXm
Division Sign Off
peral. Restorative, Division of Ge and Neurological De
510(k) Number K051671
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