(553 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a low-level laser therapy device, with no mention of AI or ML.
Yes
The device is indicated for providing temporary relief of pain associated with iliotibial band syndrome, which is a therapeutic purpose.
No
The device is indicated for providing temporary relief of pain, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "low level laser therapy device" and emits "infrared energy," indicating it is a hardware device that produces physical energy.
Based on the provided information, the Acculaser™ Pro4 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome." This describes a therapeutic application on the human body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "low level laser therapy device" that emits infrared energy. This is consistent with a physical therapy or pain management device, not a device used for analyzing biological samples.
- 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 or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Acculaser™ Pro4 falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acculaser™ Pro4 is indicated for adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome.
Product codes (comma separated list FDA assigned to the subject device)
NHN
Device Description
The Acculaser™ Pro4 is a low level laser therapy device. It is non-thermal and emits infrared energy at 830 nm.
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)
Bench test and clinical performance data demonstrate that the Acculaser™ Pro4 low level laser therapy device is safe and effective in providing adjunctive therapy for the temporary relief of pain and disability associated with ITBS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
023660
1/2
Sponsor: PhotoThera, Inc.
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MAR 1 9 2004
510(k) SUMMARY-Acculaser™ Pro4
ubmitter Name: Photo Thera, Incorporatud Career Children Comments of Arm
| Submitter Address: | 2260 Rutherford Rd.
Suite 101
Carlsbad, CA 92008 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackson Streeter, M.D.
Chief Executive Officer |
| Phone Number: | 760-496-3700 |
| Fax Number: | 760-496-3707 |
| Email: | jstreeter@photothera.com |
| Date Prepared: | September 13, 2002 |
| Device Trade Name: | Acculaser™ Pro 4 |
| Device Common Name: | Low level laser therapy device |
| Classification Name: | Lamp, Non-heating, for Adjunctive Use in Pain Therapy
21 CFR 890.550; NHN |
| Predicate Devices: | K020657, Acculaser, Inc., Acculaser™ Pro LLLT
K010175, MicroLight Corp., MicroLight 830™ Laser System
K012580, TUCO Innovations, Inc., TUCO Erchonia PL2000 |
| Device Description: | The Acculaser™ Pro4 is a low level laser therapy device. It is
non-thermal and emits infrared energy at 830 nm. |
| Intended Use: | The Acculaser™ Pro4 is indicated for adjunctive use in providing
temporary relief of pain associated with iliotibial band syndrome. |
.
1
| Sponsor:
PhotoThera, Inc. | K02 3060 2/2
Acculaser™ Pro4
Traditional 510(k) Premarket Notification |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing: | Bench test and clinical performance data demonstrate that the
Acculaser™ Pro4 low level laser therapy device is safe and
effective in providing adjunctive therapy for the temporary relief of
pain and disability associated with ITBS. |
| Conclusion: | Based on the same intended use and similarity in design and
technological characteristics, the Acculaser™ Pro4 is substantially
equivalent to the predicate devices. |
.
:
.
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the circumference of the circle.
Public Health Service
MAR 1 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PhotoThera, Inc. c/o Ms. Patsy Trisler Regulatory Consultant 5610 Wisconsin Avenue, Suite 304 Chevy Chase, Maryland 20815
Re: K023060
Trade/Device Name: Acculaser™ Pro 4 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating, for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: December 22, 2004 Received: December 22, 2004
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 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.
3
Page 2 - Ms. Patsy Trisler
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Miriam C Provost
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
4
Sponsor: PhotoThera, Inc.
610(k) Number (if known):
Device Name;
Acculaser™ Pro4
Indications for Use:
The Acculaser™ Pro4 is indicated for adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) | |
| Miriam C. Provost | |
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K023060 |
Section 4.0