(364 days)
Not Found
No
The device description explicitly states that the program is electronic timed through mechanical relays instead of software for simplicity and reliability, and there is no mention of AI or ML in the document.
Yes
The device is indicated to "treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris," which signifies a therapeutic purpose.
No
This device is indicated to treat dermatological conditions, specifically moderate inflammatory Acne Vulgaris, and its description focuses on light output specifications and operational details for treatment, not diagnosis. The information provided does not mention any diagnostic capabilities.
No
The device description explicitly states that the program is electronic timed through mechanical relays instead of software, and it describes physical components like a base unit, power supply, electronic control unit, lamp housing, and a three-part arm.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris." This describes a therapeutic treatment applied directly to the patient's skin, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a light source and its delivery system for applying light to the skin. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body.
- Providing information for diagnosis, monitoring, or screening.
- Using reagents or assays.
The device is a phototherapy system, which is a type of medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Soundskin Phototherapy System is a visible light source of high spectral purity, it provides uniform illumination of red light and blue light within the same lamp housing. The output is pre-tuned to one wavelength for each light, with a narrow spectral bandwith of 635 +/-5nm for red light and an output of 435 +/- 5nm bandwidth for blue light. The light output is 2460 mW ner sa cm of the treatment area with a lamp efficiency of 95% of the nutput. This compares with laser outputs which are approximately 2300-2500 mW per sq cm of area covered when measured in joules the output can average between 15 and 600 per sq cm. We have supplied technical data sheets and charts for the information requested.
The Soundskin system is in three parts, the hase unit contains the power supply and electronic control unit, the programme is electronic timed through mechanical relays instead of software for simplicity und reliability. The red light runs for 10 minutes then changes to blue light for 10 minutes, at the end of the 20 minute cycle it automatically shuts off. There is a separate mains supply switch attached to the base unit and a single on off switch on the lamp housing everything is uutomatic operation. A three part arm attached to the base unit supports the lamp housing, the head is attached to the end of the arm with a multifunctional positioning for natient treatment. The automatic controlled electronics operate from a single reset button on the lamp housing for easy access.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based upon an analysis of the overall performance characteristics for the Soundskin Light device, BHC. International believes that no significant differences exist hetween this system and the predicate system quoted. Therefore, the Soundskin Phototherapy System raises no new issues of safety and the clinical trials prove the effectiveness is the same.
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
JAN 8 2005 K040103 1/2
Image /page/0/Picture/1 description: The image shows the logo for BH Circuits LTD. The logo includes a check mark and the letters Q, M, S, and E. The logo also includes the text "ISO 9002 REGISTERED FIRM" and "GB 1562 Electronic Design & Manufacturers".
1 8 20BHC International Ltd.
Smart Peel"" Skin Exfoliation Technology
Derma - Light Coloured Light Therapy
Image /page/0/Picture/5 description: The image is a black and white logo featuring a globe with the continents of North and South America, Africa, and Europe visible. The text "World leaders of Innovative Technology" is arranged in a circular fashion at the top of the globe. The text "Skin Resurfacing & Rejuvenation Equipment" is arranged in a circular fashion at the bottom of the globe. The logo appears to represent a company that is a global leader in skin resurfacing and rejuvenation technology.
510(k) Summary of safety and Effectiveness for the Soundskin Phototherapy System
This 510(k) Summary of safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92
General Information 1.
Submitter
Contact Person
BHC International Ltd 18 Stapledon Road Orton Southgate Peterborough PE2 6TD United Kingdom
Michael Breen 400 Lathrop Avenue Suite 200 River Forest IL 60305 USA Tel: 708 366 6626 Fax: 708 366 5655
Summary Preparation Date
Wednesday, 20 October 2004
- Names
Device Name:
Classification Name
Soundskin Phototherapy System
Laser Instrument, Surgical Powered Product Code: GEX Panel: 79
- Predicate Devices
The Soundskin Phototherapy System is substantially equivalent to the Lumenis Clearlight (K013623)
1
Image /page/1/Picture/0 description: The image shows the logo for B H Circuits Ltd. The logo includes a check mark and the letters Q, M, and S. The logo also includes the text "GB 1562 Electronic Design & Manufacturers."
40103 2/2
BHC International Ltd.
Smart Peel ™ Skin Exfoliation Technology
Derma - Light Coloured Light Therapy
Image /page/1/Picture/5 description: The image shows a black and white logo of a globe. The text "World Leaders of Innovative Technology" is written in a circular fashion around the top of the globe. The text "Skin Resurfacing & Rejuvenation Equipment" is written in a circular fashion around the bottom of the globe. The globe itself is a wireframe design, with the continents shown in solid black.
4. Device Description
The Soundskin Phototherapy System is a visible light source of high spectral purity, it provides uniform illumination of red light and blue light within the same lamp housing. The output is pre-tuned to one wavelength for each light, with a narrow spectral handwidth of 635 +/-5nm for red light and an output of 435 +/- 5nm bandwidth for blue light. The light output is 2460 mW ner sa cm of the treatment area with a lamp efficiency of 95% of the nutput. This compares with laser outputs which are approximately 2300-2500 mW per sq cm of area covered when measured in joules the output can average between 15 and 600 per sq cm. We have supplied technical data sheets and charts for the information requested.
The Soundskin system is in three parts, the hase unit contains the power supply and electronic control unit, the programme is electronic timed through mechanical relays instead of software for simplicity und reliability. The red light runs for 10 minutes then changes to blue light for 10 minutes, at the end of the 20 minute cycle it automatically shuts off. There is a separate mains supply switch attached to the base unit and a single on off switch on the lamp housing everything is uutomatic operation. A three part arm attached to the base unit supports the lamp housing, the head is attached to the end of the arm with a multifunctional positioning for natient treatment. The automatic controlled electronics operate from a single reset button on the lamp housing for easy access.
-
న్ Indications for use
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris. -
Performance duta ().
Based upon an analysis of the overall performance characteristics for the Soundskin Light device, BHC. International believes that no significant differences exist hetween this system and the predicate system quoted. Therefore, the Soundskin Phototherapy System raises no new issues of safety and the clinical trials prove the effectiveness is the same.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three swooping lines representing its wings or feathers.
JAN 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BHC International Ltd. c/o Mr. Michael Breen 400 Lathrop Avenue, Suite 200 River Forest, Illinois 60305
Re: K040103 Trade/Device Name: Soundskin Phototherapy System 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: December 21, 2004 Received: December 22, 2004
Dear Mr. Breen:
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 may or babyer to de 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. Michael Breen
This letter will allow you to begin marketing your device as described in your Section 510(k) I ma letter will and 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Muriam C. Provost
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
4
Indications for Use
510(k) Number (if known)
Device Name
Soundskin Phototherapy System
Indications for use
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.
Prescription Use X Yes AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUF ON ANOTHER I'AGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040103