(127 days)
Not Found
No
The summary describes a light therapy system with different light modules and positioning options. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated to treat dermatological conditions, including acne vulgaris and superficial, benign vascular, and pigmented lesions, and for specific ultraviolet radiation therapy for diagnosed skin disorders. These are all therapeutic applications.
No
The device is described as a "Skin Therapy System" that emits light for the treatment of dermatological conditions and diagnosed skin disorders. Its intended uses are for therapy, not diagnosis.
No
The device description explicitly states it is an "AC illumination source consisting of one or more light modules" and describes physical components like light modules, a positioning arm, and a pedestal. This indicates a hardware-based device, not software-only.
Based on the provided information, the VersaClear Skin Therapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- VersaClear Function: The VersaClear Skin Therapy System is an illumination source that applies light directly to the patient's skin for therapeutic purposes (treating dermatological conditions). It does not involve testing samples taken from the body.
- Intended Use: The intended use clearly describes treatment of skin conditions, not diagnosis through sample analysis.
- Device Description: The description focuses on the light source and its application to the body, not on analyzing biological samples.
Therefore, the VersaClear Skin Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VersaClear System is intended to provide phototherapeutic light to the body. The VersaClear is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Product codes
GEX, FTC
Device Description
The VersaClear™ Skin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or more light modules. A set of light modules emits a specific narrow spectrum of light, namely blue (420 ± 2nm), red (615 ± 3nm), or UVA (368 ± 3nm). The light modules are mounted on a positioning arm attached to a mobile or stationary pedestal, a wall, or a countertop. This flexible design accommodates varying office spatial settings, and allows for the treatment of patients who are sitting, reclining, or lying down. Light modules are interchangeable to maximize System versatility.
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)
The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues. On this basis, the VersaClear System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031805, K030883, K030426, K043329, K885025, K041212, K841795
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
SEP 2 0 2005
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K05/259". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with distinct strokes and curves.
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
| Submitter's name: | TheraLight, Inc. | |
|---|---|---|
| Submitter's Address: | 2794 Loker Avenue West, Suite 105 | |
| Carlsbad, CA 92008 | ||
| Telephone: | (760) 930-8000 | |
| Contact: | Kevin E. Daly | |
| Chief Operating Officer | ||
| Date Prepared: | May 13, 2005 | |
| Device Trade Name: | VersaClear™ Skin Therapy System | |
| Device Common Name: | VersaClear™ Skin Therapy System | |
| Device Classification Name: | Laser surgical instrument for use in general and | |
| plastic surgery and in dermatology (ref. 21 CFR | ||
| 878.4810); Ultraviolet lamp for dermatologic / skin | ||
| disorders (ref. 21 CFR 878.4630). | ||
| Predicate Devices: | Blu-U Photodynamic Therapy Illuminator | |
| Dusa Pharmaceuticals, Inc. | ||
| K031805 | ||
| Omnilux Blue | ||
| Photo Therapeutics, Ltd. | ||
| K030883 | ||
| Omnilux Red | ||
| Photo Therapeutics, Ltd. | ||
| K030426 | ||
| Omnilux Revive and Blue | ||
| Photo Therapeutics, Ltd. | ||
| K043329 | ||
| HOUVA II UVA | ||
| National Biological Corporation | ||
| K885025 | ||
| HOUVA 3 Phototherapy System | ||
| National Biological Corporation | ||
| K041212 | ||
| Predicate Devices (cont'd): | UV 1000 | |
| Waldmann Lichttechnik | ||
| K841795 |
.
.
.
1
Device Description:
The VersaClear™ Skin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or more light modules. A set of light modules emits a specific narrow spectrum of light, namely blue (420 ± 2nm), red (615 ± 3nm), or UVA (368 ± 3nm). The light modules are mounted on a positioning arm attached to a mobile or stationary pedestal, a wall, or a countertop. This flexible design accommodates varying office spatial settings, and allows for the treatment of patients who are sitting, reclining, or lying down. Light modules are interchangeable to maximize System versatility.
Intended Use and Indications for Use:
The VersaClear System is intended to provide phototherapeutic light to the body. The VersaClear is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Performance Data:
The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues. On this basis, the VersaClear System is substantially equivalent to the predicate devices.
Conclusion:
On the basis of the information provided in this Summary, TheraLight believes that the VersaClear Skin Therapy System is substantially equivalent to legally commercialized predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2005
Mr. Kevin E. Daly Chief Operating Officer TheraLight, Inc. 2794 Loker Avenue West, Suite 105 Carlsbad, California 92008-6616
Re: K051259 Trade/Device Name: VersaClear™ Skin Therapy 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, FTC Dated: September 2, 2005 Received: September 6, 2005
Dear Mr. Daly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection o re(t) possession is substantially equivalent (for the indications felerenced above and nave decembers and marketed predicate devices marketed in interstate for use stated in the encrosate) to regard as a many and call be vice Amendments, or to commerce prior to May 20, 1976, the exactions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Ac. (710t) that do not require to the general controls provisions of the Act. The 1 ou may, merelore, manel the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified (500 as roy als. Existing major regulations affecting your device can may be subject to sublications, 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 r least be advised that I Dris issualles syour device complies with other requirements of the Act that I Drehan statutes and regulations administered by other Federal agencies. You must or any I coolar statutes and submitted to: registration and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 007, adoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic fordling the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Mr. Kevin E. Daly
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Budrin
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K051259
Device Name: VersaClear™ Skin Therapy System
Indications for Use:
The VersaClear Skin Therapy System is generally indicated to treat dermatological The Versachour Dimi- modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light modules vulgaris. Technique of moderate inflammatory acne vulgaris, and for use alone the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated of superietar, beling in vasoa.ca, are ultraviolet radiation therapy for diagnosed skin disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Chabala Buchup for MKM
Division of Ge neral. Restorative. and Neurological De
510(k) Number.
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