(78 days)
Not Found
No
The device description mentions an "embedded microprocessor" for control, but there is no mention of AI, ML, or related concepts in the provided text. The focus is on the laser technology and safety features.
Yes
The device is indicated for the treatment of various medical conditions such as benign cutaneous vascular lesions, rosacea, port wine stains, warts, scars, striae, psoriasis, inflammatory acne vulgaris, and wrinkles, implying a therapeutic purpose.
No
The device is described as a "laser system" indicated for "photocoagulation" and "treatment" of various benign lesions and conditions, which are therapeutic rather than diagnostic actions. Its description focuses on delivering laser energy for treatment.
No
The device description clearly states it is a "flash-lamp excited pulsed dye medical laser" and describes hardware components like an optical fiber, hand piece, cryogen delivery system, and safety interlock systems. While it mentions an "embedded microprocessor" for control, the core functionality and delivery of therapy are hardware-based.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Candela Family of Pulse Dye Laser Systems are medical lasers used for photocoagulation and treatment of various cutaneous lesions and conditions. This involves applying energy directly to the patient's body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is therapeutic, not diagnostic based on in vitro analysis.
The device is a therapeutic medical device that uses laser energy for treatment, not an IVD that analyzes biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Candela Family of Pulse Dye Laser Systems is indicated for the following uses in:
General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles.
Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
New Indication: Treatment of Benign Epidermal Pigmented Lesions
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Candela Family of Pulse Dye Laser Systems are flash-lamp excited pulsed dye medical lasers, controlled by an embedded microprocessor., to be used for the following uses in: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. For treatment of benign cutaneous vascular lesion, such as facial and leg Dermatology/Plastic Surgery: telangiectasia, rosacea, port wine stains, hemangiomas, angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles. Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.
The Lasers may be used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a hand piece. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the hand piece . The Candela Family of Pulsed Dye Laser Systems 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
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 Family of Pulsed Dye Laser Systems are required to conform and do conform to the Laser Performance Standard (21 CFR 1040). In addition the lasers conform to the Harmonized Standard EN 60601 1-2, Part 2 established by and required by the European Community.
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.
K001093, K021180, K033331, K033461, K031488, K984424, K024206, K024371
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black and white, with the top half being solid black and the bottom half being made up of horizontal white stripes. The word "CANDELA" is in a sans-serif font and is also black.
FEB - 9 2005
510(k) Summary
General Information:
The purpose of this premarket notification application is to provide notification of substantial equivalence of the Candela Family of Family of Pulsed Dye Laser Systems, which are substantially equivalent to previously marketed devices intended for the following indications General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg Donnatoregor raine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles. Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.
New Indication: Treatment of Benign Epidermal Pigmented Lesions
There have been no modifications in design of the Lasers in the Pulsed Dye Family of Laser Systems which were previously cleared under K001093, K021180, K033331 and K033461.
| Submitted by: | Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lorraine Calzetta |
| Date prepared: | November 12, 2004 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use
in General and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, Family of Pulsed Dye Laser Systems |
Predicate Devices
| Candela
SPTL
1B
Laser | Candela
Cbeam
Pulsed
Dye
Laser
(aka | Candela
Vbeam
Pulsed
Dye
Laser | Cynosure
e Apogee | Laserscope Aura
KTP
Laser | GentelLA
SE
Family of
laser
Systems |
| -------------------------------- | ---------------------------------------------------- | -------------------------------------------- | ---------------------- | --------------------------------- | ------------------------------------------------- |
|---|
1
Candela Family of Pulsed Dye Laser Systems 510k Summary
| Clearbeam | |||||
|---|---|---|---|---|---|
| am) | |||||
| K001093 | K02118 | K03346 | K031488 | K984424 | K024371 |
| 0 | 1 | K024206 | |||
| K03333 | |||||
| 1 |
Description:
The Candela Family of Pulse Dye Laser Systems are flash-lamp excited pulsed dye medical lasers, controlled by an embedded microprocessor., to be used for the following uses in: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. For treatment of benign cutaneous vascular lesion, such as facial and leg Dermatology/Plastic Surgery: telangiectasia, rosacea, port wine stains, hemangiomas, angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles. Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.
New Indication: Treatment of Benign Epidermal Pigmented Lesions
The Lasers may be used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a hand piece. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the hand piece . The Candela Family of Pulsed Dye Laser Systems 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.
Testing:
As a laser product, the Family of Pulsed Dye Laser Systems are required to conform and do conform to the Laser Performance Standard (21 CFR 1040). In addition the lasers conform to the Harmonized Standard EN 60601 1-2, Part 2 established by and required by the European Community.
Summary of Substantial Equivalence:
The Candela Family of Pulsed Dye Laser Systems is equivalent in key design aspects, functional features and indications for use as the predicate devices for the treatment of epidermal pigmented lesions.
On the basis of similarities in functional features, method of operation, and intended uses, Candela Corporation believes that the Candela Family of Pulsed Dye Laser Systems are substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human figures, representing the department's focus on people and their well-being.
Public Health Service
FEB - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lorraine Calzetta Patrovic Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
Re: K043251
Trade/Device Name: Candela Family of Pulsed Dye Laser Systems 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: November 12, 2004 Received: November 23, 2004
Dear Ms. Patrovic:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encrease of the enactment date of the Medical Device Amendments, or to conimered processified in accordance with the provisions of the Federal Food, Drug, de nees mat have been revat do not require approval of a premarket approval application (PMA). and Cosmetic (11ct) the market the device, subject to the general controls provisions of the Act. The r ou may, arerely missis of the Act include requirements for annual registration, listing of general controll proving 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 If your device is elabilition (sontrols. Existing major regulations affecting your device can may be subject to basil additions, 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 1 loase be advised that i Drivisation of our device complies with other requirements of the Act that I Dri has Intact a and regulations administered by other Federal agencies. You must of any I outer states and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K ratt 607), adoning (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Lorraine Calzetta Patrovic
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w yours ough finding of substantial equivalence of your device to a legally prematics notification. Thesults 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 rr you attire of Compliance at (240) 276-0115. 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 other general mionnational 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/industry/support/index.html.
Sincerely yours,
Mark A. Wilkerson
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
Indications for Use
510(k) Number (if known):
Device Name: Candela Family of Pulsed Dye Laser Systems
Indications For Use:
The Candela Family of Pulse Dye Laser Systems is indicated for the following uses in:
General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles.
Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
New Indication: Treatment of Benign Epidermal Pigmented Lesions
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(k) Number