(154 days)
Not Found
No
The provided text describes a laser system for dermatological procedures, focusing on wavelengths, pulse duration, and intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality.
Yes
The device is intended for various medical procedures such as laser tattoo removal, treatment of vascular and pigmented lesions, and skin resurfacing for acne scars and wrinkles, all of which are therapeutic interventions.
No
The device's stated Intended Use and Specific Indications describe treatments such as incision, excision, ablation, vaporization, and removal/reduction of various skin conditions, all of which are therapeutic interventions rather than diagnostic procedures. The device description also focuses on the delivery of laser energy to tissue for clinical effects, again indicating a treatment function.
No
The device description clearly outlines a physical laser unit with a console, articulated arm, handpieces, and footswitch, indicating it is a hardware-based medical device that delivers laser energy.
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 description clearly states that this device is a laser system used for direct treatment of soft tissue and skin through incision, excision, ablation, vaporization, coagulation, and hemostasis. It delivers energy to the tissue to achieve a clinical effect.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to act on the body.
- Intended Use: The intended use and specific indications all describe procedures performed directly on the patient's skin and soft tissue.
Therefore, this device falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: 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: blue and black)
- Nevus of Ota
- Removal or lightening of hair with or without adjuvant preparation.
- Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece)
- . Tattoo removal (light ink: red, sky blue, green)
- Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, . spider angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, . solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
- Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The entire 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 (532 nm and 1064 nm) or optional Multilite Dye Laser Handpiece (650 nm and 585 nm). The user activates laser emission by means of a footswitch.
The RevLite Systems are designed to provide laser energy for use in a variety of dermatological procedures (see indications for use). The 532 nm and 1064 nm wavelengths and optional 650 nm and 585 nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very narrow laser pulses (5-20 ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
None
Description of the test set, sample size, data source, and annotation protocol
None
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): 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.
K072564, K033461, K021180, K013748, K053608, K964074
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) Premarket Notification - Original Submission
RevLite™ Q-Switched Nd:YAG Laser System, New Indication for Use
December 19, 2008
HOYA ConBio™
47733 Fremont Boulevard, Fremont, C
510-445-4500 www.conbio.com 510
| Submitter: | HOYA ConBio, Inc.
47733 Fremont Blvd.
Fremont, California 94538
Phone: 510-445-4500
Fax: 510-445-4550 | JUN - 1 2009 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Mr. Jim Green
Vice President of Engineering | |
| Date Summary Prepared: | April 3, 2009 | |
| Device Trade Name: | RevLite™ Q-Switched Nd:YAG Laser Systems | |
| 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(s): | Alma, Harmony XL Multi-Platform (Q-Switched Nd:YAG hand
piece) (K072564)
Candela VBeam, VBeam Laser (K033461, K021180) and
Sclerolaser (K013748)
Cynosure, Photogenica/VLS- Star Laser (K053608)
Iridex, Diolite2- 532 (K964074) | |
| Device Description: | The entire 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 (532 nm and 1064 nm)
or optional Multilite Dye Laser Handpiece (650 nm and 585 nm).
The user activates laser emission by means of a footswitch. | |
Proprietary
Section 5: Page 2
1
510(k) Premarket Notification -- Original Submission RevLite™ Q-Switched Nd:YAG Laser System, New Indication for Use December 19, 2008
The RevLite Systems are designed to provide laser energy for use in a variety of dermatological procedures (see indications for use). The 532 nm and 1064 nm wavelengths and optional 650 nm and 585 nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very narrow laser pulses (5-20 ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue. .
General: Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis
Specific: For use for the following indications: Treatment of Epidermal Pigmented Lesions, Treatment of Dermal Pigmented Lesions. Nevus of Ota. 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. Benign cutaneous lesions, such as, but not limited to: striae and scars. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength).
The RevLite™ Laser Systems are comparable to their predicate devices in terms of their indications for use, technical specifications, operating performance features, and general design features.
Nonclinical Performance Data:
Intended Use:
Comparison:
None
None.
Clinical Performance Data:
Additional Information:
None requested at this time.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an emblem of an eagle with its wings spread, clutching what appears to be a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HOYA ConBio, Incorporated % Ms. Lisa Burns Liza Burns and Associates 19722 Westview Drive Twain Harte, California 95383
JUN - 1 2009
Re: K083899
Trade/Device Name: RevLite™Q-Switched Nd:YAG Laser 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 15, 2009 Received: May 18, 2009
Dear Ms. Burns:
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 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); medical device reporting
3
Page 2-Ms. Liza Burns
(reporting of medical device related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
RevLite™ Q-Switched Nd: YAG Laser System
Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
183896
Specific Indications :.
1064 nm wavelength
- Tattoo Removal (dark ink: blue and black)
- Nevus of Ota
- Removal or lightening of hair with or without adjuvant preparation.
- Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece)
- . Tattoo removal (light ink: red, sky blue, green)
- Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, . spider angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, . solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
- Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
AND/OR
KA O gilling to m King (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083899
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Proprietary
Section 4: Page 2
5
510(k) Premarket Notification – Original Submission RevLite™ Q-Switched Nd: YAG Laser System, New Indication for Use March 23, 2009
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
( 879年32 816 国産品番号 2007年度の2007年
Neils Dale Forman
(Division Sign-Off) (Division Sign of Surgical. Orthopedic, and Restorative Devices
510(k) Number K083899
Proprietary