(13 days)
No
The 510(k) summary describes a laser system with fixed parameters and does not mention any AI/ML components or capabilities.
Yes
The device is intended for the treatment of various skin lesions, which is a therapeutic purpose.
No
The device description and intended use clearly state that it is for "treatment" of various lesions, not for diagnosis.
No
The device description clearly states it is a "continuous-wave frequencydoubled diode-pumped Nd: Y AG laser system" with specific power outputs and a delivery mechanism via "fiber optic and handpiece," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Nuvolase 532 Function: The Nuvolase 532 Laser System is a therapeutic device that uses a laser to treat conditions on the skin. It directly interacts with the patient's tissue to achieve a therapeutic effect.
The description clearly states its intended use is for treating vascular and pigmented lesions of the skin, and the device description details a laser system for delivering energy to tissue. This is a direct treatment method, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Nuvolase 532 Laser System for Ophthalmology is intended for use in the treatment of vascular lesions of the skin, including capillary hemangioma (port wine stain), strawberry hemangioma, telangiectasia, and rosacea. It is also intended for pigmented lesions including freckles, age spots, café-au-lait, and lentigo.
VASCULAR LESIONS:
- CAPILLARY HEMANGIOMA (PORT-WINE STAIN)
- STRAWBERRY HEMANGIOMA
- TELANGIECTASIA
- ROSACEA
PIGMENTED LESIONS:
- FRECKLES
- AGE SPOTS
- CAFE-AU-LAIT
- LENTIGO
Product codes
GEX
Device Description
The Nuvolase 532 Cutaneous Laser System is a continuous-wave frequencydoubled diode-pumped Nd: Y AG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. The maximum power level to tissue is 2.5 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Not Found
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.
0
3/22/99
System for Opthalmology Nuvolase 532 L American Laser Medical, Inc. March 5, 1999
KA9078D
Summary of Safety and Effectiveness
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact:
Daniel Hoefer American Laser Medical, Inc. 1832 South 3850 West Salt Lake City, UT 84104 (801) 972 1311, FAX (801) 972 5251
Name of Device:
Trade Name: Nuvolase 532 Cutaneous Laser System
Common Name: Dermatology Laser
Classification Name: Laser Instrument, Surgical, powered (per 21 CFR 878.4810)
Predicate Devices:
The Nuvolase 532 Laser System for Opthalmology has been modified from the American Laser Medical, Inc. Nuvolase 660 Laser System, K970667.
Description of Device:
The Nuvolase 532 Cutaneous Laser System is a continuous-wave frequencydoubled diode-pumped Nd: Y AG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. The maximum power level to tissue is 2.5 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and handpiece.
1
Intended Use:
The Nuvolase 532 Laser System for Ophthalmology is intended for use in the treatment of vascular lesions of the skin, including capillary hemangioma (port wine stain), strawberry hemangioma, telangiectasia, and rosacea. It is also intended for pigmented lesions including freckles, age spots, café-au-lait, and lentigo.
Technological Characteristics/Device Comparison:
The Nuvolase 532 Laser Sysem is a modification of the Nuvolase 660 Laser System, already in legal commercial distribution. Each of the systems optically pumps an Nd: Y AG crystal using 808 nm diodes 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 line, 532 nm greeen. The continuous wave beam is then shuttered electro-mechanically to produce the desired exposure durations. Each device is intended for treatement of vascular and pigmented lesions of the skin. The delivery system is equivalent in each case.
Conclusion:
The device modification does not affect the indications for use, materials, method of manufacture, or technology of the legally marketed device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three flowing lines representing the body and head. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 1999
Mr. Daniel Hoefer Regulatory Affairs American Laser Medical, Inc. 1832 South 3850 West Salt Lake City, Utah 84104
Re: K990780 Trade Name: Nuvolase 532 Cutaneous Laser System Regulatory Class: II Product Code: GEX Dated: March 5, 1999 Received: March 9, 1999
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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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,
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
4
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_ NUVOLASE 532 CUTANEOUS LASER SYSTEM
Indications For Use:
...
..........................................................................................................................................................................
VASCULAR LESIONS:
-
- CAPILLARY HEMANGIOMA (PORT-WINE STAIN)
-
- STRAWBERRY HEMANGIOMA
-
- TELANGIECTASIA
-
- ROSACEA
PIGMENTED LESIONS:
-
- FRECKLES
-
- AGE SPOTS
-
- CAFE-AU-LAIT
-
- LENTIGO
ﮩ
(PLEASE DO NOT WRITE BELOW 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 | K990780 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |