(75 days)
No
The device description focuses entirely on the optical and laser physics principles of wavelength conversion and beam shaping. There is no mention of any computational processing, algorithms, or data analysis that would indicate the presence of AI or ML.
Yes
The device is indicated for medical treatments such as "Tattoo Removal," "Treatment of Vascular Lesions," "Treatment of Pigmented Lesions," and "Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology," which are therapeutic applications.
No
The device description and intended uses clearly describe laser systems used for treatment procedures such as tattoo removal, vascular and pigmented lesion treatment, and soft tissue incision/excision, not for diagnostic purposes.
No
The device description clearly details physical components like handpiece accessories, optical fibers, lenses, Nd:YAG rods, mirrors, Brewster Plates, and KTP crystals, indicating it is a hardware-based laser system with accessories, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions on the human body (tattoo removal, vascular lesions, pigmented lesions, soft tissue procedures). IVDs are used to diagnose conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The description details a laser system designed to deliver energy to the skin and soft tissue. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the device described is a therapeutic laser system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: Y AG Handpiece Accessories are indicated for the following uses:
Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Product codes
GEX
Device Description
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 Nd:YAG Handpiece Accessory consists of a cylindrical housing connecting to the distal end of the optical fiber which plugs into the standard Candela Family of Q-Switched Alexandrite Laser (AlexLaze) systems. The fiber carries the 755nm light from the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems to the handpiece at the distal end where the wavelength conversion from 755mm to 532nm occurs. The principle of operation is outlined here. The 755nm light is focused by focusing lenses to a 2mm beam waist within an Nd: YAG rod situated in the heart of the converter module. It is known that Nd: Y AG can be pumped at 755nm and made to lase at 1064nm with high efficiency. The Nd: YAG rod has two appropriately coated mirrors, one on either side, to form a laser resonator. Within the laser resonator is a Brewster Plate which ensures that the output 1064nm beam is polarized (in another variation of the same scheme, the Nd:YAG will be replaced by Nd:YVO4 or similar gain medium which provides a naturally polarized output, eliminating the need for a Brewster Plate). The output of the Nd: YAG laser has the same pulse duration as the original 755nm laser, but the wavelength is now 1064mm. The 1064nm beam is then incident on a KTP crystal that is aligned for optimum phase matching for second harmonic generation at 1064mm. The KTP crystal converts 1064mm to 532nm efficiently. A dichroic beam-splitter separates the 532nm beam from the residual unconverted 1064m. The 532nm beam is appropriately shaped and sized using lenses and is incident on the skin during treatment. The unconverted 1064nm that is rejected by the beam-splitter is safely absorbed in a beam dump within the module.
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 1064 Nd: YAG Handpiece Accessory is very similar to the 532nm handpiece except that there is no KTP crystal for the 1064nm to 532nm conversion. The beam is extracted immediately after the Nd: Y AG laser resonator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Tissue
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" in all caps on the right. The flame is black and white, with horizontal lines inside the flame shape. The word "CANDELA" is in a simple, sans-serif font.
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510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92.
Submitter Information
| Company Name: | Candela Corporation | |
|---|---|---|
| Company Address: | 530 Boston Post Road | |
| Wayland, MA 01778 | DEC 20 2006 | |
| Company Phone: | 508-358-7400 | |
| Company Facsimile: | 508-358-5602 | |
| Contact Person: | Mr. Jeffrey Roberts | |
| Manager, Regulatory Affairs | ||
| Date summary Prepared: | 10/05/06 | |
| Device Identification |
Device Trade/Proprietary Name: Candela Family of Q-Switched Alexandrite Laser
| (AlexLAZR) Systems: 532 and 1064 Nd:YAG Handpiece | |
|---|---|
| Accessories | |
| Common Name: | Q-Switched Alexandrite Laser |
| Classification Name: | Laser Surgical Instrument, for use in General and Plastic |
| Surgery and Dermatology | |
| Classification Regulation: | 21 CFR § 878.4810 |
| Device Classification: | II |
Identification of Predicate Device
| Predicate Device(s): | Hoya ConBio, Inc., formerly Continuum Electro-Optics, Inc. |
|---|---|
| Medlite C3 Q-Switched Nd:YAG Laser, K011677 | |
| Candela Q-Switched, Frequency Doubled, Nd:YAG Laser | |
| System, K942152 | |
| Candela Q-Switched Alexandrite Laser (AlexLAZR), K955662 |
Device Description
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 Nd:YAG Handpiece Accessory consists of a cylindrical housing connecting to the distal end of the optical fiber which plugs into the standard Candela Family of Q-Switched Alexandrite Laser (AlexLaze) systems. The fiber carries the 755nm light from the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems to the handpiece at the distal end where the wavelength conversion from 755mm to 532nm occurs. The principle of operation is outlined here. The 755nm light is focused by focusing lenses to a 2mm beam waist within an Nd: YAG rod situated in the heart of the converter module. It is known that Nd: Y AG can be pumped at 755nm and made to lase at 1064nm with high efficiency. The Nd: YAG rod has two appropriately coated mirrors, one on either side, to form a laser resonator. Within the laser resonator is a Brewster Plate which
1
ensures that the output 1064nm beam is polarized (in another variation of the same scheme, the Nd:YAG will be replaced by Nd:YVO4 or similar gain medium which provides a naturally polarized output, eliminating the need for a Brewster Plate). The output of the Nd: YAG laser has the same pulse duration as the original 755nm laser, but the wavelength is now 1064mm. The 1064nm beam is then incident on a KTP crystal that is aligned for optimum phase matching for second harmonic generation at 1064mm. The KTP crystal converts 1064mm to 532nm efficiently. A dichroic beam-splitter separates the 532nm beam from the residual unconverted 1064m. The 532nm beam is appropriately shaped and sized using lenses and is incident on the skin during treatment. The unconverted 1064nm that is rejected by the beam-splitter is safely absorbed in a beam dump within the module.
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 1064 Nd: YAG Handpiece Accessory is very similar to the 532nm handpiece except that there is no KTP crystal for the 1064nm to 532nm conversion. The beam is extracted immediately after the Nd: Y AG laser resonator.
Description of Intended Use
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: YAG Handpiece Accessories are indicated for the following uses:
Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Rationale for Substantial Equivalence
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: YAG Handpiece Accessories have the same intended use and utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system) as the predicate devices.
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: YAG Handpiece Accessories shares similar methods of assembly, method of operation and intended uses, and therefore is substantially equivalent to the currently legally marketed Hoya ConBio Inc., Medlite C3 Q-Switched Nd:YAG Laser, K011677, Candela Q-Switched, Frequency Doubled, Nd: YAG Laser System, K942152, and Candela Q-Switched Alexandrite Laser (AlexLAZR), K955662.
Safety and Effectiveness Information
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: Y AG Handpiece Accessories are substantial equivalent to the currently legally marketed Hoya ConBio Inc., Medlite C3 Q-Switched Nd: YAG Laser, K011677, Candela O-Switched, Frequency Doubled, Nd: YAG Laser System. K942152, and Candela O-Switched Alexandrite Laser (AlexLAZR), K955662 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices.
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We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: YAG Handpiece Accessories.
Conclusion
Base on the similarities in indications for use, design features, and functional features Candela Family of Q-Switched Alexandrite Laser (Alex147R) Systems: 532 and 1064 Nd: YAG Handpiece Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2006
Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778
Re: K063072
Trade/Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: Y AG Handpiece Accessories 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: October 5, 2006 Received: October 10, 2006
Dear Mr. Roberts:
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
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Page 2 - Mr. Jeffrey Roberts
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), please contact the Office 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Kumn
DEP
D
Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063072
Device Name: Candela Family of O-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd. YAG Handpiece Accessories
Indications for Use:
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: Y AG Handpiece Accessories are indicated for the following uses:
Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number K062072