(78 days)
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: An accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a Laser or Intense Pulse Light System for their legally marketed indications. Its handpiece produces a negative pressure over the skin surface just prior to the administration of the treatment beam through it. The chamber of the handpiece produces the negative pressure over the skin surface for a very short duration just prior to firing an intense treatment light pulse or laser beam. The negative pressure results in the flattening of the skin against a highly thermal conductive transparent sapphire window, thereby ensuring tight mechanical contact with the window. The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System consists of a control unit and a handpiece connected together by a 10' flexible hose containing flexible tubing. The flexible hose has a connector at the front of the control unit and is removable by pulling a connector while pressing a latch. The handpiece is ergonomically designed for easy use.
The provided document is a 510(k) summary for the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System. This submission is for an accessory system that works with existing laser or intense pulsed light (IPL) systems for hair removal and pain reduction during treatment.
The document indicates that the submission relies on substantial equivalence to predicate devices (K062589 and K001589) rather than presenting a de novo study with specific performance acceptance criteria for the new device. Therefore, explicit acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial with specific endpoints, are not provided for this 510(k) submission.
Instead, the submission states that:
- "Performance clinical data demonstrates that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System does not introduce new issues of safety and efficacy and therefore is substantially equivalent to the currently legally marketed Inolase Serenity PSF™ (Pneumatic Skin Flattening) System, K062589 and Candela Dynamic Cooling Device, K001589 predicate devices."
- "Performance clinical data demonstrates that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System does not introduce new issues of safety and efficacy."
This suggests that comparison data, likely from clinical observations or existing studies on the predicate devices, was used to support the claim of substantial equivalence. However, the details of these "performance clinical data" are not elaborated in the 510(k) summary.
Given the information provided in the 510(k) summary, it's not possible to populate a table of acceptance criteria and reported device performance directly from a new study, nor can the requested details about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies be provided. This type of information is typically part of a full clinical study report, which is not included in a 510(k) summary.
In summary, the provided 510(k) document is a declaration of substantial equivalence based on prior predicate devices, not a report of a new clinical study with defined acceptance criteria for the submitted device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a logo with a stylized flame-like shape on the left and the word "CANDELA" on the right. The flame shape is black and has horizontal lines within it, giving it a textured appearance. The word "CANDELA" is in a simple, sans-serif font, with each letter clearly defined and evenly spaced.
pg 1 of 2
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 | AUG 15 2007 |
|---|---|---|
| Company Address: | 530 Boston Post RoadWayland, MA 01778 | |
| Company Phone: | 508-358-7400 | |
| Company Facsimile: | 508-358-5602 | |
| Contact Person: | Mr. Jeffrey RobertsManager, Regulatory Affairs | |
| Date summary Prepared: | May 25, 2007 | |
| Device Identification | ||
| Device Trade/Proprietary Name: | The Candela - Inolase Serenity PSFTM (Pneumatic SkinFlattening) System | |
| Common Name: | Laser or Intense Pulse Light Handpiece Accessory System | |
| Classification Name: | Laser Surgical Instrument, for use in General and PlasticSurgery and Dermatology | |
| Classification Regulation: | 21 CFR § 878.4810 | |
| Device Classification: | II | |
| Identification of Predicate Device |
The Inolase Serenity PSF™ (Pneumatic Skin Flattening) System Predicate Device(s): K062589 The Candela Dynamic Cooling Device, K001589
Device Description
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a Laser or Intense Pulse Light System for their legally marketed indications. Its handpiece produces a negative pressure over the skin surface just prior to the administration of the treatment beam through it.
The chamber of the handpiece produces the negative pressure over the skin surface for a very short duration just prior to firing an intense treatment light pulse or laser beam. The negative pressure results in the flattening of the skin against a highly thermal conductive transparent sapphire window, thereby ensuring tight mechanical contact with the window.
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System consists of a control unit and a handpiece connected together by a 10' flexible hose containing flexible tubing. The
1
{1}------------------------------------------------
KO71469
pg 2 of-2
flexible hose has a connector at the front of the control unit and is removable by pulling a connector while pressing a latch. The handpiece is ergonomically designed for easy use.
Description of Intended Use
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses:
An accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.
Reduction of pain during Laser or Intense Pulse Light System treatment.
Rationale for Substantial Equivalence
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System has the same technological characteristics, materials, design aspects, and energy source as the currently legally marketed Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System), K062589 and the same parent device light source, indication, and clinical modality as the currently legally marketed Candela Dynamic Cooling Device, K001589.
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System has the same intended use and shares similar technological characteristics including methods of assembly and method of operation as the legally marketed Inolase Serenity PSF™ (Pneumatic Skin Flattening) System, K062589 predicate devices. Performance clinical data demonstrates that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System does not introduce new issues of safety and efficacy and therefore is substantially equivalent to the currently legally marketed Inolase Serenity PSF™ (Pneumatic Skin Flattening) System, K062589 and Candela Dynamic Cooling Device, K001589 predicate devices.
Safety and Effectiveness Information
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is substantial equivalent to the currently legally marketed Inolase Serenity PSF™ (Pneumatic Skin Flattening) System, K062589 and Candela Dynamic Cooling Device, K001589 predicate devices in intended use and technological features. Performance clinical data demonstrates that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System does not introduce new issues of safety and efficacy.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the Candela - Inolase Serenity PSFTM (Pneumatic Skin Flattening) System.
Conclusion
Base on the similarities in indications for use, design features, and functional features the Candela - Inolase Serenity PSFTM (Pneumatic Skin Flattening) System has been shown to be substantially equivalent to the current legally marketed predicate devices.
2
{2}------------------------------------------------
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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778
AUG 1 5 2007
Re: K071469
Trade/Device Name: Candela – Inolase Serenity PSF™ (Pneumatic Skin Flattening) System 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 25, 2007 Received: May 29, 2007
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
{3}------------------------------------------------
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. Molkerson
Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
Pg 1 of 1
510(k) Number (if known): KD71469
Device Name: Candela - Inolase Serenity PSFTM (Pneumatic Skin Flattening) System
Indications for Use:
The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses:
An accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.
Reduction of pain during Laser or Intense Pulse Light System treatment.
| Prescription Use | X(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 ON NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | L071469 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 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.