(87 days)
Not Found
No
The device description and performance studies focus on the mechanical function of pneumatic skin flattening and its impact on pain and erythema, with no mention of AI or ML.
Yes
The device is indicated for "reduction of pain during Laser or Intense Pulse Light System treatment," which directly addresses a physiological symptom.
No
Explanation: The device is an accessory to a laser or IPL system used for hair removal. Its function is to flatten the skin, expel blood, reduce pain, and lessen post-treatment erythema during laser or IPL treatment. It does not diagnose any condition.
No
The device description explicitly mentions a "handpiece" with a "sapphire window" and the ability to produce a "vacuum," indicating physical hardware components beyond just software.
Based on the provided information, the Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is as an accessory for laser or intense pulsed light systems for hair removal, specifically to reduce pain and potentially erythema during treatment. This is a therapeutic or procedural accessory used directly on the patient's skin.
- Device Description: The description details a system that applies negative pressure to the skin to flatten it and facilitate laser/IPL treatment. This is a physical manipulation of tissue during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Serenity Pro PSF™ System does not perform any analysis of biological specimens.
The device's function is to enhance the delivery and effectiveness of a laser or IPL treatment performed in vivo (on the living body).
N/A
Intended Use / Indications for Use
The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: As 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 treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 380-680 mbar. Suction can be delivered through its handpiece. which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
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)
A clinical study was conducted with the primary objective to confirm that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System (PSF) reduces laser therapy associated pain. Evaluation consisted of pain experienced in treated sites with PSF compared with treated sites without PSF. The measurement of immediate post treatment subject pain was recorded utilizing a modified McGill Pain questionnaire. A secondary objective was to confirm that the use of PSF decreased the erythema associated with current laser therapy. Clinical investigators rated erythema immediately and 20 minutes post treatment for standard laser treatment vs. laser with PSF. The results indicated that the PSF system significantly reduces the pain associated with laser hair removal and that the side effect of erythema was lessened with PSF vs. without PSF standard laser treatment.
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.
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
K07-2925
Pg 1 of 2
510(k) Summar
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
Somerset, MA 02726
-
- (a) Submitter's George J. Hattub Address: MedicSense, USA 291 Hillside Avenue
-
- (b) Manufacturer Inolase, Ltd. 13 Giborei Israel St., PO Box 8497 Address: Netanya (New Industrial Area) Israel, 42504 JAN 1 0 2008
Mfg. Phone: 972-9-865-6750
Date:
Contact Person: Raphi Shavit, CEO
Revised- December 26, 2007 (revisions bolded)
-
- Device & Laser Handpiece Accessory System (Class 2), Product Code GEX, Classification Name: 21 CFR 878.4810 - Tradename of device: Serenity Pro PSF™ System Inolase Serenity PSF™ (Pneumatic Skin Flattening) Systems (K071469), (K071943) Predicate Devices: 3. & (K062589) 4. Description: The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 380-680 mbar. Suction can be delivered through its handpiece. which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.
- The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: 5. Intended Use: As 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 treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.
-
- Comparison of Technological With respect to technology, the Serenity Pro PSF™ is substantially Characteristics: equivalent to its predicate device. No changes have been made to the technology. The purpose of the 510(k) was to expand its indications for use for the device.
1
K07 2925 P.2 01-2
510(k) Summary
7. Performance Data: The basis for substantial equivalence for this device (K072925) relies upon the clinical data which was submitted in K071469. K071469 was determined to be substantially equivalent by FDA on 8/15/2007.
This data was obtained in a clinical study. The primary objective of the study was to confirm the assumption that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System (PSF) reduces laser therapy associated pain. This study involved normal laser treatment parameters which were typically expected to be painful. Evaluation consisted of pain experienced in treated sites with PSF compared with treated sites without PSF. The measurement of immediate post treatment subject pain was recorded utilizing a modified McGill Pain questionnaire, which is commonly used in pain evaluation.
A secondary objective of this clinical study was to confirm that the use of PSF decreased the erythema associated with current laser therapy. The clinical investigators rated erythema immediately and 20 minutes post treatment for standard laser treatment laser vs. laser with PSF.
The results of the clinical data indicated that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System (PSF) significantly reduces the pain associated with laser hair removal and that the side effect of erythema was lessened with PSF vs. without PSF standard laser treatment.
In terms of fundamental technology and intended use, the device (K071469), which was utilized in the clinical study, is essentially the same as the device (K072925), which is subject of this 510(k) submission. Therefore, this clinical study is relevant to this 510(k) submission and, Candela - Inolase has concluded that no new safety or efficacy issues have been raised.
2
K072925 Pd lotl
Indications for Use
510(k) Number (if known):
Device Name: Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System
Indications For Use:
The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses:
As 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 treatment beam through it.
Reduction of pain during Laser or Intense Pulse Light System treatment.
Prescription Use (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
3
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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2008
Inolase, Ltd. % MedicSense, USA Mr. George J. Hattub. RAC & COE Senior Staff Consultant 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K072925
Trade/Device Name: Candela-Inolase Serenity Pro 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: October 9, 2007 Received: October 24, 2007
Dear Mr. Hattub:
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
4
Page 2 -- Mr. George J. Hattub
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K072925 pg 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System
Indications For Use:
The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses:
As 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 treatment beam through it.
Reduction of pain during Laser or Intense Pulse Light System treatment.
Prescription Use (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)
(Division Sign-Off)
Division of General, Restorative,
Page
and Neurological
Page 1 of 1
510(k) Number |
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