(89 days)
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No
The device description and the lack of mentions of AI, ML, or related concepts strongly suggest this is a traditional laser system without AI/ML components.
Yes
The device's intended use is for "Retinal and Macular photocoagulation" and "Trabeculoplasty," which are medical procedures performed to treat ocular conditions, indicating a therapeutic purpose.
No
The intended use of the device is for photocoagulation and trabeculoplasty, which are therapeutic laser treatments, not diagnostic procedures. The device description also details a laser system for treatment.
No
The device description clearly states it is a "continuous wave frequency-doubled diode-pumped Nd: YAG laser system" and mentions hardware components like a laser, fiber optic, and slit lamp.
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 taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The NuvoLase Model 660 is a laser system used for photocoagulation and trabeculoplasty. These are surgical procedures performed directly on the eye, not tests performed on specimens outside the body.
- Intended Use: The intended uses listed (Retinal and Macular photocoagulation, Trabeculoplasty) are all direct treatments of the eye.
Therefore, based on the provided information, the NuvoLase Model 660 is a therapeutic laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty.
Indications For Use:
- Retinal and Macular photocoagulation
- Trabeculoplasty
Product codes
86 HOF, GEX
Device Description
The NuvoLase Model 660 is a continuous wave frequency-doubled diode-pumped Nd: YAG laser system. Treatment beam power output for the NuvoLase 660 laser is adjustable to a maximum of 2.0 Watts continuous wave at 532 nm. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 660 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 to the laser 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
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
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Summary of Performance Studies
Not Found
Key Metrics
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Predicate Device(s)
The Prima 532 marketed by Nidek, Inc., and the Oculight GL marketed by IRIS Medical Instruments.
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.
0
Nuvo-Lase 660 Laser System American Laser Medical, Inc. July 8, 1997
510(k) Summary
97256/
:
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact:
Daniel Hoefer American Laser Medical رتون 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251
Name of Device:
| Trade Name: | NuvoLase 660 Laser System |
|---|---|
| Common Name: | Ophthalmic Laser Photocoagulator |
| Classification name: Ophthalmic Laser (per 21 CFR 886.4930) | |
| Product Code: 86 HOF |
Predicate Devices:
The NuvoLase 660 is substantially equivalent to the following legally marketed devices: The Prima 532 marketed by Nidek, Inc., and the Oculight GL marketed by IRIS Medical Instruments.
Description of Device:
The NuvoLase Model 660 is a continuous wave frequency-doubled diodepumped Nd: YAG laser system.
1
Nuvo-Lase 660 Laser System American Laser Medical, Inc. July 8, 1997
Treatment beam power output for the NuvoLase 660 laser is adjustable to a maximum of 2.0 Watts continuous wave at 532 nm. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 660 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 to the laser by fiber optic.
Intended Use:
The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty.
Technological Characteristics/Device Comparison:
The NuvoLase 660 Laser System is substantially equivalent to the Nidek Prima 532 and the IRIS Oculight GL Laser Photocoagulator already in commercial distribution. Each of these systems optically pumps an Nd: YAG crystal (NuvoLase 660 and Oculight GL using 808 nm diodes, Prima 532 using flashlamps) to produce laser light at 1064 nm. This light passes through a second crystal which exhibits a non-linear optical response, re-emitting the laser energy at the first harmonic of the 1064 nm line, 532 nm green. The continuous wave beam is then shuttered either mechanically or electro-optically to produce the desired exposure durations.
Each of these devices is intended for use in retinal photocoagulation, iridotomy, and trabeculoplasty. Each is a 532 nm true continuous wave device, generated by a frequency doubled diode pumped Nd: YAG crystal. Laser energy is delivered by equivalent delivery devices in each case.
Conclusion:
The NuvoLase 660 Laser System is substantially equivalent to the Prima 532 marketed by Nidek, Inc. and the Oculight GL marketed by Iris Medical Instruments, already in legal commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, and precautions are all substantially the same.
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a staff entwined by a serpent, representing healing and medicine. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel Hoefer American Laser Medical, Inc. 1832 South 3850 West Salt Lake City, Utah 84104
OCT - 6 1007
Re: K972561 Trade Name: NuvoLase 660 Laser System Regulatory Class: II Product Code: GEX Dated: July 8, 1997 Received: July 9, 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,
Sincerely yours,
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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K972561 `10(k) Number (if known):
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Device Name: NuvoLase 660 Laser System
Indications For Use:
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Retinal and Macular photocoagulation
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Trabeculoplasty
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OOE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K972561 |
| Prescription Use | ✓ | OR | Over The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |