(50 days)
The Candela Family of Pulse Dye Laser Systems Pigmented Lesion Handpiece Accessory is indicated for the Treatment of Benign Epidermal Pigmented Lesions
The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses: The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams or elliptical beams on the skin.. The Pigmented Lesion Handpiece Accessory attaches to the standard handpiece and replaces the standard distance gauge for the treatment of benign epidermal pigmented lesions The Candela Family of Pulsed Dye Laser Systems is 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. The pigmented lesion handpiece accessory is designed for use with the Candela Pulsed Dye Laser handpiece, for the treatment of Benign Epidermal pigmented Lesions
The provided text is a 510(k) Summary for a medical device (Candela Family of Pulsed Dye Lasers Pigmented Lesion Handpiece Accessory) and does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of acceptance criteria for a clinical study measuring device performance (e.g., lesion clearance rates, skin reaction scores). Instead, it refers to regulatory compliance and safety standards.
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| CDRH Laser Performance Standard (21 CFR 1040) | The Candela Family of Pulsed Dye Laser Systems conforms to this standard. |
| Electrical Safety Standard (IEC 60601-1) | The Candela Family of Pulsed Dye Laser Systems conforms to this standard. |
| Biocompatibility (ISO 10993-1) | All materials contacting the patient conform to the requirements of this standard for biocompatibility. |
| Substantial Equivalence to Predicate Devices | The device is deemed substantially equivalent to K043251, K040200, and K001746 based on "similarities in key design aspects, intended uses and materials." |
| Indication for Use | "Treatment of Benign Epidermal Pigmented Lesions." No specific performance metrics for this indication are provided in this summary. |
2. Sample Size for Test Set and Data Provenance:
The document does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the clinical performance of the pigmented lesion handpiece accessory. The "Testing" section focuses on regulatory compliance for laser and electrical safety, and biocompatibility, rather than clinical efficacy/safety studies for the accessory's intended use.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. As there's no mention of a clinical study with a test set that required ground truth establishment, these details are absent.
4. Adjudication Method for the Test Set:
This information is not provided in the document, as there is no mention of a clinical test set that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported in this document. The focus is on regulatory clearance through substantial equivalence, not on comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not conducted or reported. This device is a laser accessory, not an AI algorithm.
7. Type of Ground Truth Used:
This information is not provided as no specific clinical study data requiring ground truth for efficacy assessment is presented. The "ground truth" for regulatory clearance is based on adherence to established safety and performance standards for laser products and materials, and comparison to predicate devices.
8. Sample Size for the Training Set:
This information is not applicable/not provided. The device is a physical laser accessory, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reason as above.
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K05135°
Candela Family of Pulsed Dye Lasers Pigmented Lesion Handpiece Accessory
Image /page/0/Picture/2 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 on the left side and has horizontal lines on the right side.
JUL 13 2005
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Family of Pulsed Dye Lasers Pigmented Lesion Handpiece Accessory is indicated for use with the Candela Family of Pulse Dye Lasers for the Treatment of Benign Epidermal Pigmented Lesions.
| Submitted by: | Candela Corporation530 Boston Post RoadWayland, MA 01778-1886 |
|---|---|
| Contact Person: | Lorraine Calzetta |
| Date prepared: | May 13, 2005 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for usein General and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, Candela Family of Pulse Dye Laser Systems |
| Predicate Devices: | |
| Candela Family of Pulsed Dye Lasers - K043251MSQ Family of Laser/Light System Handpieces - K040200Lumenis Light Sheer - K001746 |
Description:
The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses:
The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams or elliptical beams on the skin.. The Pigmented Lesion Handpiece Accessory attaches to the standard handpiece and replaces the standard distance gauge for the treatment of benign epidermal pigmented lesions
The Candela Family of Pulsed Dye Laser Systems is 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.
The pigmented lesion handpiece accessory is designed for use with the Candela Pulsed Dye Laser handpiece, for the treatment of Benign Epidermal pigmented Lesions
Testing:
As a laser product, the Candela Family of Pulsed Dye Laser Systems conforms to the CDRH Laser Performance Standard (21 CFR 1040). And IEC 60601-1.Electrical Safety Standard.
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K051359, p. 2 of 2
Candela Family of Pulsed Dye Laser Systems Pigmented Lesion Handpiece Accessory 510(k) St
All materials contacting the patient conform to the requirements Of the FDA recognized
and and and 1970-1950-1999-1 An maters standard ISO 10993-1.
Summary of Substantial Equivalence:
On the basis of similarities in key design aspects, intended uses and materials, Candela
nd I and Children and Cardely Cardely of Pulced Dye Laser Systems Pigmented L On the basis of similarites in Rey design aspects, "Inchibed Daser Systems Pigmented Lesion
Corporation believes that its Candela Family of Pulsed Dye Laser Systems Pigmented Corporation beneves that its Candola Fullary of a the predicate devices.
Handpiece Accessory is substantially equivalent to the predicate devices.
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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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2005
Ms. Lorraine Calzetta Patrovic Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
Re: K051359
KU51359
Trade/Device Name: Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory 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: May 20, 2005 Received: May 24, 2005
Dear Ms. Patrovic:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10).) premainted in the marketed in interstate for use stated in the enclosure) the setering and devices marketed in interstate for use stated in the encrosure for tegally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 20, 1970, the chaomicine and be provisions of the Federal Food, Drug, devices that have been reclassified in accerdance what a premarket approval applications of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls, provisions o You may, inerelore, market the device, subject to use general registration, listing of
general controls provisions of the Act include requirements for annual registrations on general controls provisions of the Fet merator requires 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 classified (see above) nito entire consisted on affecting your device can
may be subject to such additional controls. Title may be subject to such additional controller Links. Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Code of Feactal Regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalenee determination does not mean Please be advised that FDA s issualles of a substition with other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a determination administered by other Federal agencies. You must as and ligit or any Federal statules and regulations administered of registration and listing (2)
comply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, morams, manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Fart 601); good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path; 11 CFR 1000 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
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Page 2 - Ms. Lorraine Calzetta Patrovic
This letter will allow you to begin marketing your device as described in your Section 510(k)
. This letter will allow you to begin maketing your active equivaler of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your dev premarket notification. The FDA micing of substance of the more of thus, permits your device ッツ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the received in the 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 If you desire specific advice for your at not on our of the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation contact the Office of Complance at (217) 217 Seat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain "Misbranding by relerence to premarket nonification (consection the Division of Small
other general information on your responsibilities under the Act from the (800) 638-204 other general information on your responsion at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its lindustry(support/index) ht Manufacturers, International and Consumer Fibebance arch colored thindustry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K05 1359
Device Name:
Candela Family of Pulsed Dye Laser Systems : Pigmented Lesion Handpiece Accessory
Indications For Use:
- The Candela Family of Pulse Dye Laser Systems Pigmented Lesion Handpiece . Accessory is indicated for the 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)
Page 1 of 1
- vision Sich-On Division of General, Restorative and Neurological Division of Generalive and Neurological, Rest
s(k) Number K051359
§ 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.