(273 days)
Not Found
No
The description focuses on LED light delivery and massage, with no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is indicated to treat dermatological conditions, specifically moderate inflammatory acne vulgaris, and to provide topical heating for increased blood flow, muscle relaxation, and pain relief, which are therapeutic uses.
No.
The device's intended use is to deliver LED light for treatment of dermatological conditions, promote increased blood flow, and relieve pain, not to diagnose a condition.
No
The device description explicitly mentions a "base unit" containing power supplies and a control unit, and "attachable Pulsators" that deliver light. These are hardware components, not solely software.
Based on the provided information, the RevLight device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that RevLight is used to provide LED light to the body for treating dermatological conditions, promoting blood flow, relaxation, and pain relief. These are all in vivo applications, meaning they are performed on a living organism (the body).
- Device Description: The description details a device that delivers light to the skin surface. This aligns with a therapeutic or cosmetic device, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The RevLight's function falls outside this definition.
N/A
Intended Use / Indications for Use
RevLight is intended for use to provide LED light to the body, and with the large pulsators, facial massage. Depending on the wavelength(s) of light delivered by the detachable Pulsators that are connected to the base unit, RevLight is: 1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
Product codes
GEX
Device Description
RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies and the control unit. Attachable to the base unit are three sets of Pulsators that deliver the light to the skin as they are moved over the skin surface. The output of the Pulsators ranges from 420-940nm.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001179, K030883, K030426, K013623, K022266, K033946, K040103, K9354597
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
JUN 2 7 2005
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510(k) Summary, K042630
| Applicant | Skincare Technology Inc.
119 W. Hubbard St.
Suite 300
Chicago, IL 60610 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | June 8, 2005 |
| Device Name | RevLight® Skincare System |
| Common Name | LED phototherapy |
| Classification name | Laser Instrument, Surgical Powered
Procode: GEX |
| Summary of Substantial
Equivalence | RevLight® is substantially equivalent in respect to the intended
use, design and method of operation to numerous cleared devices,
including:
Product /510(k)
LED Systems
Super Nova/Acubeam (K001179)
OmniLux Blue (K030883)
Revive (OmniLux Red) (K030426)
ClearLight (K013623)
Aurora SR (K022266;K033946(supp))
Lovely I (K033946)
Soundskin Phototherapy System (K040103)
Massagers
Model HM-45 (K9354597) |
| Device Description | RevLight is a device that utilizes Light Emitting Diodes to provide
LED light to the body. The base unit contains the power supplies
and the control unit. Attachable to the base unit are three sets of
Pulsators that deliver the light to the skin as they are moved over
the skin surface. The output of the Pulsators ranges from 420-
940nm. |
| Intended Use and
Indications | RevLight is intended for use to provide LED light to the body, and
with the large pulsators, facial massage. Depending on the
wavelength(s) of light delivered by the detachable Pulsators that
are connected to the base unit, RevLight is:
- generally indicated to treat dermatological conditions and
specifically indicated to treat moderate inflammatory acne
vulgaris (Blue Pulsators); and
generally indicated to provide topical heating to promote
increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators). |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Erri-
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 2005
Skincare Technologies Incorporated C/o Richard O. Wood Bell, Boyd & Lloyd, LLC 70 West Madison Street, Suite 3300 Chicago, Illinois 60602-4207
Re: K042630
Trade/Device Name: RevLight® Skin Care 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: May 12, 2005 Received: May 13, 2005
Dear Mr. Wood:
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 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.
2
Page 2 – Richard O. Wood
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin matically of substantial equivalence of your device to a legally promatics notification. "The aclassification 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 arrive ior your and (240) 276-0115 . Also, please note the regulation entitled, Colliact the Office of Compuner as (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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,
Miriam C. Prevost, RN
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K042630_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
| Device Name: | RevLight® Skin Care System |
|---|---|
| Indications for Use (Large | |
| and Small Pulsators) | RevLight is intended for use to provide LED light to the |
| body. | |
| Indications for Use (Large | |
| Pulsators) | Facial massage. |
| Blue Pulsators | Used with the RevLight, are generally indicated to treat |
| dermatological conditions and specifically indicated to treat | |
| moderate inflammatory acne vulgaris. | |
| Amber Pulsators | Used with the RevLight, are generally indicated to provide |
| topical heating to promote increased blood flow, for | |
| temporary relaxation of muscle and relief of pain. | |
| Red Pulsators | Used with the RevLight, are generally indicated to provide |
| topical heating to promote increased blood flow, for | |
| temporary relaxation of muscle and relief of pain. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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 Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K042630
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