(195 days)
Not Found
No
The description focuses on light emission and basic controls (duration, intensity selection). There is no mention of AI/ML terms, image processing, or data-driven decision making.
Yes
The device is described as treating a dermatological condition (moderate inflammatory acne vulgaris) and provides "phototherapeutic light," which are clear indications of a therapeutic purpose.
No
The device is described as a "Skin Care Light" intended to provide phototherapeutic light to treat dermatological conditions like moderate inflammatory acne vulgaris. Its function involves emitting visible light to treat, not to diagnose, a condition.
No
The device description clearly states it includes hardware components such as a lamp, spectral band light source, controlling keys, mechanical fixture, and an electronic unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Skin Care Light device applies light directly to the surface of the skin for therapeutic purposes (treating acne). It does not analyze any biological samples taken from the body.
- Intended Use: The intended use clearly states it provides "phototherapeutic light to the face" and "treat dermatological conditions by exposing the surface of the skin." This is an external, therapeutic application, not an in vitro diagnostic test.
Therefore, the Skin Care Light is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Skin Care Light is intended to provide phototherapeutic light to the body.It is generally indicated to treat dermatological conditions. Skin Care Light is specifically indicated to treat moderate inflammatory acne vulgaris.
Skin Care Light is intended to provide phototherapeutic light to the face. It is used to treat dermatological conditions by exposing the surface of the skin to the blue spectrum. It is specifically indicated to treat moderate inflammatory acne vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Skin Care Light is a lamp intended to treat dermatological conditions by emitting visible light in blue and/or red.The energy intensity are 4,8,12mW/c m².The system includes a spectral band light source and some controlling keys to select light.It also includes mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area,an electronic unit to control the duration,it will automatically shut off after 15 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body, face
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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 as required by section KO70870 807.92(c)
007 ) 0 2007
Submitted by:TRANSVERSE INDUSTRIES CO.
NO.305 HUA CHENG RD.HSIN-CHUANG
CITY TAIPEI,TAIWAN R.O.C.
TEL:886-2-85218692
FAX:886-2-85216662
Contact Person: HO KO LIANG
Prepared On : April 02,2007
K24
- 1 -
1
Classification Name : Laser Instrument,Surgical Powered.
Common or Usual name: Light Therapy Device
Proprietary Name: Skin Care Light
Classification : The subject device satisfies the 21 CFR definition of a class 2
,Laser surgical instrument for use in general and plastic
| Regulation
Number | Product Code | Regulation Name | Review
Panel |
|----------------------|--------------|--------------------------------------------------------------------------------------------|---------------------------------|
| 878.4810 | GEX | Laser surgical instrument for use
in general and plastic surgery and
in dermatology. | General &
Plastic
Surgery |
surgery and in dermatology as follows :
Substantial Equivalence :
Skin Care Light is substantially equivalence with the ClearLight Phototherapy Device,Model CL 420 ( K013623 ) made in Israel.Skin Care Light has the equivalent intended use and different technological characteristics.
Device Description :
Skin Care Light is a lamp intended to treat dermatological conditions by emitting visible light in blue and/or red.The energy intensity are 4,8,12mW/c m².The system includes a spectral band light source and some controlling keys to select light.It also includes
2
mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area,an electronic unit to control the duration,it will automatically shut off after 15 minutes.
Statement of Indication For Use :
Skin Care Light is intended to provide phototherapeutic light to the body.It is generally indicated to treat dermatological conditions. Skin Care Light is specifically indicated to treat moderate inflammatory acne vulgaris.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted as a staff with a serpent entwined around it, representing healing and medicine. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Transverse Industries Company % Mr. Ho Ko Liang President No. 305 Hua Cheng Road Hsin-Chuang City, Taipei, China (Taiwan)
Re: K070870 Trade/Device Name: Skin Care Light 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: September 18, 2007 Received: September 18, 2007
Dear Mr. Liang:
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.
OCT 1 0 2007
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
4
Page 2 - Mr. Ho Ko Liang
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. 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours. Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Mr. Ho Ko Liang
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND/GSDB D.O. f/t:KSB:kxl:10-04-07
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic. Physical Medicine & Anesthesiology Devices Br. | 240-276-0120 |
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Indications for Use
510(k) Number ( if known ) : K070870 Device Name : Skin Care Light Indication For Use :
Skin Care Light is intended to provide phototherapeutic light to the face. It is used to treat dermatological conditions by exposing the surface of the skin to the blue spectrum. It is specifically indicated to treat moderate inflammatory acne vulgaris.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ ( Part 21 CFR 801 Subpart D )
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ ( Part 21 CFR 801 Subpart C )
( 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, and Neurological Devices | |
| 510(k) Number | K020680 |
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