(78 days)
None
Not Found
No
The summary describes a standard intense pulsed light system and a cooling device, with no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels, and the treatment of benign pigmented lesions, which are all therapeutic applications. The cooling device also reduces pain and discomfort during light applications.
No
The device description indicates its use for permanent hair reduction, treatment of vascular lesions, and treatment of benign pigmented lesions, all of which are therapeutic applications, not diagnostic ones. The CoolHand cooling device is also for patient comfort during these treatments.
No
The device description explicitly details hardware components such as a Xenon flashlamp, handpieces, footswitch, and specifies physical dimensions and weight, indicating it is a physical device, not software-only.
Based on the provided information, 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Photolight Pulsed Light device is described as an intense pulsed light system used for direct treatment of the body (hair reduction, vascular lesions, pigmented lesions). It applies light energy to the skin.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens taken from the patient.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Photolight PL is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
The CoolHand cooling device is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain and discomfort associated with light applications.
Product codes
GEX
Device Description
Photolight PL is a intense pulsed light system, having a Xenon flashlamp located in the handpieces. It is a light source with a range approximately 400 - 1400 nm wavelength. Emission activation is by footswitch. Overall weight of the laser is 18 Kg, and the size is 20x48x54 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
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)
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EsteLux pulsed light system
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
510(K) Summary
K031258 - 10, 1
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | JUL 0 8 2003 |
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | April 18, 2003 |
| Device Trade Name: | Photolight PL |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | EsteLux pulsed light system |
| Device Description: | Photolight PL is a intense pulsed light system, having a Xenon
flashlamp located in the handpieces. It is a light source with a range
approximately 400 - 1400 nm wavelength.
Emission activation is by footswitch. Overall weight of the laser is 18
Kg, and the size is 20x48x54 cm (HxWxD).
Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Photolight PL is indicated for permanent hair reduction,
photocoagulation of vascular lesions, photothermolysis of blood
vessels, treatment of benign pigmented lesions.
The CoolHand cooling device is intended to provide pre-cooling of the
epidermis, to reduce thermal injury to the epidermis, and to reduce
patient pain and discomfort associated with light applications. |
| Comparison: | The Photolight PL system has an equivalent indication for uses, the
same principle of operation, and essentially the same wavelength
range and pulse energy range as the predicate device. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Photolight PL is another safe and effective device for permanent
hair reduction, photocoagulation of vascular lesions, photothermolysis
of blood vessels, treatment of benign pigmented lesions. |
| Additional Information: | none |
1
Image /page/1/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 caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 8 2003
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K031258 Trade/Device Name: Cynosure Photolight PL Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 12, 2003 Received: June 13, 2003
Dear Mr. Cho:
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.
2
Page 2 - Mr. George Cho
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. 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) you may obtain. 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,
Miriam C. Provost
for 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
3
510(k) Number (if known): _ K031258
Device Name: Cynosure Photolight PL
Indications For Use:
The Photolight Pulsed Light device is indicated for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
The CoolHand cooling device is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain and discomfort associated with light applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
neral, Restorative and Neurological Devices
510(k) Number K031258
Prescription Use
✓
OR
Over-The-Counter Use