(30 days)
Not Found
No
The summary describes a laser system with specific wavelengths and handpieces for various dermatological procedures. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The device description focuses on the hardware and energy delivery mechanism.
Yes
The device is indicated for various medical treatments, including tattoo removal, treatment of vascular and pigmented lesions, and skin resurfacing procedures, which are therapeutic interventions.
No
The device is indicated for treatment procedures such as incision, excision, ablation, vaporization of soft tissue, tattoo removal, hair removal, and treatment of various lesions, rather than for diagnosing conditions.
No
The device description clearly states it is a "laser unit and controls are contained in a single console" and delivers energy via an "articulated arm and a specially designed MultiSpot Handpiece or optional Multilite Dye Laser Handpieces," indicating it is a hardware-based laser system, not software-only.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The RevLite O-switched Nd: YAG Laser System is a laser system designed for direct application to the patient's body for various dermatological and surgical procedures (incision, excision, ablation, tattoo removal, treatment of lesions, hair removal, skin resurfacing).
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the body's tissues.
- Intended Use: The intended use clearly describes procedures performed on the patient, not tests performed on samples from the patient.
Therefore, the RevLite O-switched Nd: YAG Laser System falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in dermatology for the following indications: Treatment of Epidermal Pigmented Lesions, Treatment of Dermal Pigmented Lesions Nevus of Ota, Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis, Laser skin resurfacing procedures for the treatment of acne scars and wrinkles, Tattoo Removal: Dark Ink: (Black & Blue) Light Ink: (Red, Sky Blue, Green), Treatment of Vascular Lesions, Removal or lightening of unwanted hair with or without adjuvant preparation
The RevLite O-switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific Indications
1064 nm wavelength:
Tattoo Removal: Dark Ink: (Black & Blue)
Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation.
Skin resurfacing procedures for the treatment of acne scars and wrinkles
532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece):
Tattoo Removal: Light Ink (Red, Sky Blue, Green)
Treatment of Vascular Lesions including, but not limited to:
- . Prot wine birthmarks
- Telangiectasias .
- Spider angioma .
- Cherry angioma .
- Spider nevi .
Treatment of Pigmented Lesions including, but not limited to: - Café-au-lait bithmarks .
- Solar lentiginos .
- Senile lentiginos .
- Becker's nevi .
- Freckles .
- Nevus spilus .
Skin resurfacing procedures for the treatment of acne scars and wrinkles.
Product codes
GEX
Device Description
The RevLite System with LCD Panel laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece or optional Multilite Dye Laser Handpieces. The user activates laser emission by means of a footswitch. The RevLite System incorporates 2 very narrow laser applications designed to apply more energy over a larger spot size at the same fluence level, enabling the physician to treat a larger area more rapidly.
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)
Nonclinical Performance Data: None
Clinical Performance Data: none
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
RevLite Q-Switched Laser System 510k Summary
Image /page/0/Picture/3 description: The image shows the logo for HOYA ConBio, along with their address, phone number, website, and fax number. The address is 47733 Fremont Boulevard, Fremont, California 94538. The phone number is 510-445-4500, the website is www.conbio.com, and the fax number is 510-445-4550.
/JAN 2 ວ 2007
| Submitter: | Hoya ConBio, Inc.
47733 Fremont Blvd.
Fremont, California 94538
Phone: 510-445-4500
Fax: 510-445-4550 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Donna K. Templeman
Regulatory Consultant |
| Date Summary Prepared: | December 21, 2006 |
| Device Trade Name: | RevLite™ Q-Switched Nd: YAG Laser System |
| Common Name: | Dermatology Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX |
| Classification Code: | 878.4810 Laser surgical instrument for use in general and plastic
surgery and in dermatology (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. |
| Equivalent Device: | RevLite C6 Q-Switched Nd: YAG Laser System - K063112 |
| Device Description: | The RevLite System with LCD Panel laser unit and controls are
contained in a single console. Electrical power is supplied to the
console by the facility's power source. Laser energy produced
within the device is delivered to the tissue by means of an
articulated arm and a specially designed MultiSpot Handpiece or
optional Multilite Dye Laser Handpieces. The user activates laser
emission by means of a footswitch. The RevLite System
incorporates 2 very narrow laser applications designed to apply
more energy over a larger spot size at the same fluence level,
enabling the physician to treat a larger area more rapidly. |
| Intended Use: | For use in dermatology for the following indications: Treatment
of Epidermal Pigmented Lesions, Treatment of Dermal
Pigmented Lesions Nevus of Ota, Incision, Excision, Ablation,
Vaporization of Soft Tissue for General Dermatology,
Dermatologic and General Surgical Procedures for Coagulation
and Hemostasis, Laser skin resurfacing procedures for the
treatment of acne scars and wrinkles, Tattoo Removal: Dark Ink:
(Black & Blue) Light Ink: (Red, Sky Blue, Green), Treatment of
Vascular Lesions, Removal or lightening of unwanted hair with or
without adjuvant preparation |
| Comparison: | The RevLite Laser System with LCD Panel is comparable to its
predicate and parent devices in terms of its indications for use,
technical specifications, operating performance features, and
general design features. |
| Nonclinical Performance
Data: | None |
| Clinical Performance Data: | none |
| Additional Information: | None requested at this time. |
:
1
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2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hoya ConBio, Inc. % Ms. Donna K. Templeton Regulatory Consultant DKT Consulting 1105 Sunset Creek Lane Pleasanton, California 94566
JAN 2 5 2007
Re: K063834
Trade/Device Name: RevLite™ Q-Switched Nd: YAG Laser Systeml Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 22, 2006 Received: December 27, 2006
Dear Ms. Templeton:
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
3
Page 2 – Ms. Donna K. Templeton
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.
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 yours
Mark N. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Ko6 3834
RevLite Q-Switched Nd: YAG Laser System Device Name:
Indications for Use:
The RevLite O-switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific Indications
1064 nm wavelength:
Tattoo Removal: Dark Ink: (Black & Blue)
Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation.
Skin resurfacing procedures for the treatment of acne scars and wrinkles
532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece):
Tattoo Removal: Light Ink (Red, Sky Blue, Green)
Treatment of Vascular Lesions including, but not limited to:
- . Prot wine birthmarks
- Telangiectasias .
- Spider angioma .
- Cherry angioma .
- Spider nevi .
Treatment of Pigmented Lesions including, but not limited to:
- Café-au-lait bithmarks .
- Solar lentiginos .
- Senile lentiginos .
- Becker's nevi .
- Freckles .
- Nevus spilus .
Skin resurfacing procedures for the treatment of acne scars and wrinkles.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
(Posted November 13, 2003)
| Proprietary Information | 510(k) Number | Page 178 | L063 834 | Page ___ of ___ |
|---|---|---|---|---|
| ------------------------- | --------------- | ---------- | ---------- | ----------------- |