(180 days)
Not Found
No
The summary describes a laser system for dermatological applications and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the treatment of facial wrinkles, which is a medical condition, making it a therapeutic device.
No
This device is indicated for treatment (facial wrinkles), not diagnosis.
No
The device description clearly states it is a laser system with multiple hardware subsystems (Optical and Laser Resonator, Cooling, Electronics and Electrical, Operator interface).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of facial wrinkles" using a laser system. This is a therapeutic application performed directly on the patient's body (in vivo).
- Device Description: The device is a laser system, which is a physical treatment modality.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat a condition on the patient's skin.
N/A
Intended Use / Indications for Use
The Laserscope Lyra TM Laser Systems & Accessories are indicated for use in the Dermatological applications for the treatment of facial wrinkles.
Product codes
GEX
Device Description
The Lyra™ Series Surgical Laser Systems are Nd: YAG lasers producing laser emission @ 1064nm. The Laserscope Lyra Surgical Laser System consists of four major subsystems: The Optical and Laser Resonator system; The Cooling system; The Electronics and Electrical system; The Operator interface.
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)
Clinical studies produced results that indicate the Laserscope Lyra" Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles.
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
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.
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Laserscope Lyra™ Surgical Laser System & Accessories 510(k) Premarket Notification
510(k) Summary
KO20021
This 510(k) Summary of Safety & Effectiveness for the Laserscope's Lyra Surgical Laser System & Accessories is submitted in accordance with the requirements of SMDA 1990 and CFR 807.92 and CFR 807.93 follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
- A.. Trade Name Lyra "M Surgical Laser System and Accessories (Nd: YAG configuration)
- B. Common Name Laser Instrument, Surgical, Powered
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- C. Establishment Registration Number 2937094
- D. Manufacturer's Identification Laserscope 3070 Orchard Drive San Jose, CA 95134-2011 (408) 943-0636 (503) 961-1688 FAX
Official Correspondent Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs
- E. Device Classification The Lyra™ Series Surgical Laser System has been specifically classified as a Class II medical device by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels.
- F. Performance Standards The Lyra™ Series Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
- G. Device Description The Lyra™ Series Surgical Laser Systems are Nd: YAG lasers producing laser emission @ 1064nm. The Laserscope Lyra Surgical Laser System consists of four major subsystems:
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1
The Optical and Laser Resonator system; The Cooling system; The Electronics and Electrical system; The Operator interface.
- G. Substantial Equivalence In the opinion of Laserscope, the Laserscope Lyra™ Surgical Laser System & Accessories is substantially equivalent in technology and intended use to the Lyra 1M Surgical Laser System FDA cleared under 510(k) K9990903, the CoolTouch Nd:YAG Laser System FDA cleared under 510(k) K003715, and the SLS NLite System FDA cleared under 510(k) K000811.
- H. Indications For Use: The Laserscope Lyra™ Laser Systems & Accessories are indicated for use in the Dermatological applications for the treatment of facial wrinkles.
- I. Nonclinical Performance Data: None.
- J. Clinical Performance Data: Clinical studies produced results that indicate the Laserscope Lyra" Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, with three faces in profile, suggesting a focus on people and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Laserscope Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs 3070 Orchard Drive San Jose, California 95134-2011
Re: K020021
Trade Name: Lyra GTM Series Laser System and Accessories (Nd: YAG configuration) Regulation Number: 878.4810 Regulation Name: Laser surgical instrument, powered Regulatory Class: II Product Code: GEX Dated: April 11, 2002 Received: April 12, 2002
Dear Mr. Hardiman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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,
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Page 2 - Mr. Paul Hardiman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Hpt Ruvelu
Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT Page 1 of 1
| 510(k) Number: | K020021 |
|---|---|
| Device Name: | LASERSCOPE LYRA TM SERIES SURGICAL |
| LASER SYSTEM & Accessories | |
| Indications for Use: | The Laserscope Lyra TM Laser Systems & Accessories are |
| indicated for use in the Dermatological applications for the |
treatment of facial wrinkles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (per 21 CFR 801.109)
Over-The-Counter-Use
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZDOZI 510(k) Number --
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