(84 days)
Not Found
No
The description focuses on the laser technology, cooling system, and embedded processor for control, with no mention of AI or ML.
Yes
The device is used for the photocoagulation and treatment of various medical conditions such as benign cutaneous vascular lesions, telangiectasia, rosacea, port wine stains, hemangiomas, spider angioma, poikiloderma of Civatte, warts, scars, striae, and also for pain reduction and skin cooling during laser treatment, all of which align with the definition of a therapeutic device.
No
Explanation: The device is described as a laser used for treatment (photocoagulation) of various benign cutaneous and vascular lesions, not for diagnosis.
No
The device description explicitly lists multiple hardware components, including a laser head, power supply, circulatory system, optical delivery system, and a Dynamic Cooling Device. While it mentions a "Software control system," this is clearly part of a larger hardware system.
Based on the provided text, 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.
- Device Description: The description clearly states that the Candela Sclero Long Pulse Laser is a medical laser that delivers energy via an optical fiber to a handpiece on to the skin. It is used for treating various skin and vascular lesions directly on the body.
- Intended Use: The intended uses listed are all related to treating conditions on the skin and in specific anatomical areas (gynecology, podiatry) through direct application of laser energy. There is no mention of analyzing samples taken from the body.
Therefore, the device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Candela Sclero Long Pulse Laser System is indicated for use in photocoagulation of benign cutaneous vascular lesion, benign cutaneous lesion, and benign cutaneous vascular lesion in gynecology.
The Candela Sclero Long Pulse Laser is indicated for the following uses:
General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.
DermatologyPlastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, spider angioma, poikiloderma of Civatte and benign cutaneous lesion, such as warts, scars, striae.
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology
Podiatry: Treatment of benign cutaneous lesion, such as warts.
The Candela Sclero Long Pulse Laser includes an integrated Dynamic Cooling Device, which is indicated for:
- the reduction in pain.
- cooling of the skin prior to laser treatment
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Sclero LP laser is a pulsed, flash lamp excited dye, medical laser, controlled by an embedded processor, to be used for the treatment of telangiectasia, port wine stains, benign cutaneous lesions and other benign cutaneous vascular lesions. The laser system has a Dynamic Cooling Device built into it which provides a short burst of cryogen spray prior to firing the laser output energy is delivered via an optical fiber to a handpiece on to the skin. The cryogen which is housed within the laser enclosure is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment.
The Candela Sclero Long Pulse system is comprised of the following components:
- High voltage power supply (HVPS) 1.
- Flashlamp laser head 2.
- Circulatory System 3.
-
- Dve fluid system
- న్. Optical delivery system
- Software control system 6.
- Dynamic Cooling Device 7.
The Candela Sclero Long Pulse Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous (skin/dermatological), gynecology
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)
As a laser product, the Sclero Long Pulse is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the device conforms to the UL 544 electrical safety standard and the Essential Requirements of the European Union Medical Device Directives.
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.
K954934, K931762, K882160, K971737, K972347, K981952, K991234
Reference Device(s):
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
§ 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
K993671
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Sclero Long Pulse Laser System, which is substantially equivalent to previously marketed devices.
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in General
and Plastic Surgery and in Dermatology) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dermatology Laser, Long Pulse Dye Laser System |
| Predicate Devices: | Candela SPTL Long Pulse/Tunable Pulse Dye Laser cleared under 510(k)
number K954934, Candela SPTL (K931762), Coherent Argon/Dye Laser
(K882160), Cynosure LPIR, Apogee 40 (K971737), Coherent VersaPulse
Laser (K972347), Instruments for Medicine and Diagnostics Spectrum
VeinLase (K981952), and Altus CoolGlide (K991234) |
Description:
The Sclero LP laser is a pulsed, flash lamp excited dye, medical laser, controlled by an embedded processor, to be used for the treatment of telangiectasia, port wine stains, benign cutaneous lesions and other benign cutaneous vascular lesions. The laser system has a Dynamic Cooling Device built into it which provides a short burst of cryogen spray prior to firing the laser output energy is delivered via an optical fiber to a handpiece on to the skin. The cryogen which is housed within the laser enclosure is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment.
The Candela Sclero Long Pulse system is comprised of the following components:
- High voltage power supply (HVPS) 1.
- Flashlamp laser head 2.
- Circulatory System 3.
-
- Dve fluid system
- న్. Optical delivery system
- Software control system 6.
- Dynamic Cooling Device 7.
The Candela Sclero Long Pulse Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.
Indication for Use:
The Candela Sclero Long Pulse Laser System is indicated for use in photocoagulation of benign cutaneous vascular lesion, benign cutaneous lesion, and benign cutaneous vascular lesion in gynecology.
Testing:
As a laser product, the Sclero Long Pulse is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the device conforms to the UL 544 electrical safety standard and the Essential Requirements of the European Union Medical Device Directives.
Summary of Substantial Equivalence:
The Candela Sclero Long Pulse Laser has the same intended use, utilizes the same operating principles and match key design aspects, including similar spot size, the same wavelength and / or the same maximum delivered power as the predicate devices.
On the basis of similarities in methods of assembly, method of operation, intended uses that its Candela Sclero Long Pulse Laser System is substantially equivalent to the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2000
Ms. Joan Clifford Clinical Research Manager Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
Re: K993671
Trade Name: Candela Sclero Long Pulse Laser System Regulatory Class: II Product Code: GEX Dated: October 29, 1999 Received: November 1, 1999
Dear Ms. Clifford:
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 (QS) 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.
2
Page 2 – Ms. Joan Clifford
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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1.
S10(k) NUMBER (IF KNOWN): K993671
Candela Sclero Long Pulse DEVICE NAME:
INDICATIONS FOR USE:
The Candela Sclero Long Pulse Laser is indicated for the following uses:
General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.
DermatologyPlastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, spider angioma, poikiloderma of Civatte and benign cutaneous lesion, such as warts, scars, striae.
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology
Podiatry: Treatment of benign cutaneous lesion, such as warts.
The Candela Sclero Long Pulse Laser includes an integrated Dynamic Cooling Device, which is indicated for:
510(k) Number .
-
- the reduction in pain.
r -
- the reduction in pain.
-
- cooling of the skin prior to laser treatment
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
- cooling of the skin prior to laser treatment
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Genera) Restorative Devices
510(k) Number K993671