(29 days)
Not Found
No
The summary describes a laser system for various dermatological procedures and does not mention any AI or ML components or functionalities.
No
The device is primarily used for aesthetic and dermatological procedures like tattoo removal, pigmented lesion removal, skin resurfacing, and treatment of benign cutaneous lesions, rather than for diagnosing, treating, or preventing diseases or medical conditions that would classify it as a therapeutic device in a medical sense.
No
Explanation: The device is a laser system used for various dermatological and surgical procedures like incision, excision, ablation, and treatment of skin conditions and lesions. Its intended uses are therapeutic (treating or altering tissue) rather than diagnostic (identifying or assessing a condition).
No
The device description explicitly states it is a "Laser System with Handpiece Adaptor" consisting of a "electrically powered Console" and delivering energy via an "articulated arm, Handpiece Adaptor and specially designed Handpieces," which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's body (incision, excision, ablation, vaporization of soft tissue, tattoo removal, treatment of lesions, etc.). IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- Device Description: The description details a laser system that delivers energy to tissue via an articulated arm and handpieces. This is consistent with a device used for direct treatment, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The device described is a therapeutic laser system used for various dermatological and surgical procedures.
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) .
- Dermal Pigmented Lesions .
- . 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
GEX
Device Description
The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor consists of a electrically powered Console in which laser energy produced within the system is delivered to the tissue by means of an articulated arm, Handpiece Adaptor and specially designed Handpieces. The user activates laser emission by means of a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Tissue (General Dermatology, Dermatologic and General Surgical Procedures)
Skin (Tattoo, Dermal Pigmented Lesions, Nevus of Ota, Hair, Acne Scars, Wrinkles, Benign cutaneous lesions, Red pigmentation in hypertrophic and keloid scars, Vascular lesions, Epidermal Pigmented lesions)
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
Special 510(k) Premarket Notification: Handpiece Adaptor RevLite Q-Switched Nd:YAG Laser System October 15, 2010
5. Special 510(k) Summary
Handpiece Adaptor Accessory for the RevLite Q-Switched Nd:YAG Laser System: Special 510k Summary
HOYA ConBio™
NOV 1 9 2010
" pl
47733 Fremont Boulevard, Fremont, California 94538
510-445-4500 www.conbio.com 510-445-4550 Fax
Submitter:
HOYA Photonics, Inc. (dba HOYA ConBio, Inc.) 47733 Fremont Blvd. Fremont, California 94538 Phone: 510-445-4500 Fax: 510-445-4550
Contact:
Donna K. Templeman Regulatory Consultant for HOYA ConBio, Inc.
October 15, 2010 Date Summary Prepared:
Device Trade Name:
RevLite Q-Switched Nd:YAG Laser System
Common Name: Dermatology Laser System
Instrument, surgical, powered, laser Classification Name: 79-GEX
878.4810 Laser surgical instrument for use in general and Classification Code: 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. ·
RevLite Q-Switched Nd:YAG Laser System (K083899) Equivalent Device:
Confidential
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1
Special 510(k) Premarket Notification: Handpiece Adaptor RevLite Q-Switched Nd:YAG Laser System October 15, 2010
The RevLite Q-Switched Nd:YAG Laser System with Device Description: Handpiece Adaptor consists of a electrically powered Console in which laser energy produced within the system is delivered to the tissue by means of an articulated arm, Handpiece Adaptor and specially designed Handpieces. The user activates laser emission by means of a footswitch. Incision, Excision, Ablation, Vaporization of Soft Tissue for Intended Use: General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Comparison: The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adapator is comparable to its parent predicate device (RevLite Q-Switched Nd:YAG Laser System with LCD) in terms of its intended use, indications for use, technical specifications, operating performance features, and general design features. Nonclinical Performance None Data: Clinical Performance Data: None Additional Information: None requested at this time.
Confidential
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hoya Photonics, Inc. % DKT Consulting Ms. Donna K. Templeman 1105 Sunset Creek Lane Pleasanton, California 94566
NOV 1 9 2010
Re: K103118
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: Class II Product Code: GEX Dated: October 15, 2010 Received: October 21, 2010 ·
Dear Ms. Templeman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
3
Page 2 – Ms. Donna K. Templeman
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Dr. Dir
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Indications for Use Statement
NOV 1 9 2010
Indications for Use Indications for Use
510(k) Number (if known): 103 118
Device Name: Handpiece Adaptor (HPA) 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.
Specific Indications:
- 1064 nm wavelength .
- Tattoo Removal (dark ink: blue and black) .
- Dermal Pigmented Lesions .
- . 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)
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Divisionofistanical Orthanddoffice of Device Evaluation (ODE) and Restorative Devices
Restorative Devices
11
Confidential
510(k) Number K103118