(89 days)
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Not Found
No
The device description focuses on the physical characteristics and operational parameters of a laser system, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in retinal and macular photocoagulation, trabeculoplasty, and iridotomy," which are medical treatments.
No
The device description and intended use indicate that the NuvoLase 720 Laser System is used for therapeutic procedures (e.g., photocoagulation, trabeculoplasty, iridotomy) rather than for diagnosing conditions.
No
The device description clearly states it is a "continuous wave argon ion laser system" and mentions hardware components like a laser, aiming beam, and fiber optic connection to a slit lamp. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- NuvoLase 720 Function: The NuvoLase 720 Laser System is a therapeutic device. It uses a laser beam to directly treat conditions within the eye (retinal and macular photocoagulation, trabeculoplasty, and iridotomy). This is an in vivo procedure (performed within the living body).
The description clearly indicates a device used for direct medical treatment, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The NuvoLase 720 Laser System is intended for use in retinal and macular photocoagulation, trabeculoplasty, and iridotomy.
Product codes
86 HQF, GEX
Device Description
The NuvoLase Model 720 is a continuous wave argon ion laser system, emitting a maximum of 2.5 watts, primarily at 488 nm and 514.5 nm wavelengths. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 720 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected by fiber optic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retinal, Macular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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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)
The AC 2200 Argon Laser Photocoagulator marketed by Nidek, Inc., and the Ultima 2000 Argon Laser Photocoagulator marketed by Coherent, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Kg276)
NuvoLase 720 Laser System American Laser Medical, Inc. July 22, 1997
OCT 21 1997
510(k) Summary
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact:
Daniel Hoefer American Laser Medical 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251
Name of Device:
| Trade Name: | NuvoLase 720 Laser System for Ophthalmology |
|---|---|
| Common Name: | Ophthalmic Laser |
| Classification name: | Ophthalmic Laser (per 21 CFR 886.4930) |
Product Code: 86 HQF
Predicate Devices:
The NuvoLase 720 is substantially equivalent to the following legally marketed devices: The AC 2200 Argon Laser Photocoagulator marketed by Nidek, Inc., and the Ultima 2000 Argon Laser Photocoagulator marketed by Coherent, Inc.
Description of Device:
The NuvoLase Model 720 is a continuous wave argon ion laser system, emitting a maximum of 2.5 watts, primarily at 488 nm and 514.5 nm wavelengths. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 720 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected by fiber optic.
1
NuvoLase 720 Laser System American Laser Medical, Inc. July 22, 1997
Intended Use:
The NuvoLase 720 Laser System is intended for use in retinal and macular photocoagulation, trabeculoplasty, and iridotomy.
Technological Characteristics/Device Comparison:
The NuvoLase 720 is an argon ion laser employing a BeO plasma tube, as does the Nidek AC2200. The Coherent Ultima utilizes a Tungsten disc plasma tube. All three emit laser light primarily at the 488 nm (blue) and 514.5 nm (green) wavelengths. Each laser system has the ability to suppress the blue portion of the output by filtering. Maximum output power levels are 2.5 Watts for the NuvoLase 720, 2.0 Watts for the Nidek AC2200, and 1.5 Watts for the Coherent Ultima 2000. Each system uses a red diode laser as the source for the aiming beam, and delivers the treatment beam via fiber optic.
Conclusion:
The NuvoLase 720 Laser System is substantially equivalent to the AC 2200 Argon Laser Photocoagulator marketed by Nidek, Inc. and the Ultima 2000 Argon Laser Photocoagulator marketed by Coherent, Inc., already in legal commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, and precautions are all substantially the same.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Daniel Hoefer . American Laser Medical, Inc. 1832 South 3850 West Salt Lake City, Utah 84104
OCT 21 1997
Re: K972765 Trade Name: NuvoLase 720 System for Ophthalmology Regulatory Class: II Product Code: GEX Dated: July 22, 1997
Received: July 24, 1997
Dear Mr. Hoefer:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Daniel Hoefer
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
tosee fo
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
- 4
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K97276)
10(k) Number (if known): _ K972765
NuvoLase 720 Laser System Device Name:
Indications For Use:
••
.
- Retinal and Macular Photocoagultation 1. .
- Iridotamy
- 2.
- Trabeculoplasty
(PLEASE DO NOT WRITE SELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K972765 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |