(151 days)
Not Found
No
The summary does not mention any AI or ML terms, image processing, or descriptions of training/test sets, which are common indicators of AI/ML use in medical devices. The device description is purely physical and energy-based.
Yes
The device is indicated for "adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome," which describes a therapeutic purpose.
No
The device is described as a "Low Level Laser Therapy Device" intended for "temporary relief of hand and wrist pain," which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it has a "hand-held treatment probe" and "emits infrared energy," indicating it is a hardware device, not software-only.
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 temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a low-level laser therapy device that emits infrared energy. This is a physical therapy modality, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Acculaser Pro is a therapeutic device applied externally to the body.
N/A
Intended Use / Indications for Use
The Acculaser Pro LLLT device is indicated for adjunctive use in the temporary relieve of hand and wrist pain associated with Carpal Tunnel Syndrome.
Product codes
NHN
Device Description
The Acculaser Pro LLLT has a hand-held treatment probe, is non-thermal, and emits infrared energy at 830nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and wrist
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
JUL 2 9 2002
Acculaser, Inc. Summary of 510(k) Premarket Notification K020657 Acculaser Pro Low Level Laser Therapy Device
Introduction
According to the requirements of 21 CFR §807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter
Address: | Owner-Operator
Acculaser, Inc.
12526 High Bluff Drive, Suite 260
San Diego, CA 92130 |
|--------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Jackson Streeter, M.D., CEO |
| Telephone: | 858-214-2258 |
| Telefax: | 858-314-2355 |
| Email: | jstreeter@acculaserinc.com |
| Date Prepared: | April 30, 2002 |
-
- Device Name:
| Proprietary name: | Acculaser Pro Low Level Laser Therapy |
|---|---|
| Common name: | Infrared laser |
| Classification Name(s) and Regulation(s): | Lamp, Non-Heating, for Adjunctive Use in Pain Therapy |
| (21 CFR §890.550); | |
| Product Code: | NHN |
.
1
- The Acculaser Pro Low Level Laser Therapy (LLLT) 3) Identification of device is substantially equivalent to MicroLight Predicate Devices to which Substantial Corporation of America's MicroLight 830TM Laser System; 510(k)-cleared by the FDA on February 6, 2002 Equivalence is claimed (K010175).
4) Device Description
The Acculaser Pro LLLT has a hand-held treatment probe, is non-thermal, and emits infrared energy at 830nm.
| 5) Intended Use | The Acculaser Pro LLLT device is indicated for adjunctive use in the temporary relieve of hand and wrist pain associated with Carpal Tunnel Syndrome. |
|---|---|
| ----------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------- |
6) Technological Characteristics and Substantial Equivalence Conclusion
The Acculaser Pro LLLT device has the same indications for use and substantially equivalent technological characteristics as the MicroLight 830™ Laser System.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2002
Acculaser, Inc. c/o Patsy J. Trisler, J.D., RAC Senior Director, PharmaNet Consulting PharmaNet, Inc. 815 Connecticut Avenue, N.W. Suite 610 Washington, DC 20006
Re: K020657
Trade/Device Name: Acculaser Pro Low Level Laser Therapy Device Regulation Number: 21 CFR 890.5500 Regulation Name: Non-Heating, for Adjunctive Use in Pain Therapy Regulatory Class: II Product Code: NHN Dated: April 30, 2002 Received: April 30, 2002
Dear Ms. Trisler:
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.
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
3
Page 2 - Ms. Patsy J. Trisler
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. 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.
R. Mark H. Millenson
Celia M. 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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Page 1 of 1
K020657 510(k) Number (if known):
Device Name: Acculaser Pro Low Level Laser Therapy Device
Indications For Use:
The Acculaser Pro Low Level Laser Therapy Device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millerson
(Optional Format 3-10-98)
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number_