(104 days)
The APL MEDICAL SYSTEM is a modular multi-laser and multi-use device and are intended for use in aesthetic, cosmetic, and surgical applications.
It is used to treat common imperfections and lesions of skin and body , including:
-
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction
-
- Laser skin treatment procedures for the treatment of:
- Acne scars .
- Wrinkles .
-
- Incision, excision, ablation, vaporization of soft tissue
- The non-ablative treatment of facial wrinkles, such as, but not limited to: 4.
- Periocular wrinkles .
- . Perioral wrinkles
-
- Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
-
- Treatment of capillaries, teleangiectasies and vascular lesions
-
- Treatment of vitiligo and psoriasis
The portable device APL MEDICAL SYSTEM, is a multi-laser and pulsed light system, designated to act on the most diffused imperfections of the skin and body. The equipmentm is conceived as an expandable system for the field of aesthetic medicine, composed of a modular platform, containing the entire electronics of the system and the cooling circuit, and a series of interchangeable hand pieces to be connected on the platform, finalized to treat specific groups of imperfections. A rapid connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform. The following hand pieces are available:
- Hand piece Pulsed Light. With the use of this hand piece the removal of unwanted hair is extremely quick and efficient, as it is possible to treat large areas (up to 9 cm2) using a single pulse or "burst" mode This system is effective on varius skin types. On this hand piece it is possible to change easily the guide light, equipped with a specific light filter and to use thus that one most adequate for the individual photo type. Furthermore, it is possible to conduct a combination of methods to attenuate facial skin imperfections related to small perorbital and labial wrinkles. With the use of guide lights within the spectrum 300-380 nm it is possible to treat psoriasis and vitiligo disease with a specific therapy. This technique has the advantage of acting directly on the concerned area while respecting the surrounding tissues.
- Hand piece Nd:Yag Laser at 1064nm, long pulse (ms). With this laser it is possible to treat teleangectasies easyly and quickly with optimal results and without leaving a cicatrix. Furthermore, it is possible to hair removal on small areas with "difficult" skin and hairs.
- Hand piece Nd: Yag Laser 1064 and 532 nm Qs (Qswitched), short pulse (ns). This laser is able to selectively destroy melanosomes through cell lysis. The Qs laser is ideal for the treatment of pigmentated lesions and in general for all superficial pigmentations, since its wavelength is well absorbed by the melanin as well as by the haemoglobin. Furthermore, the pulse width makes this type of laser selective with regards to melanosomes -i.e. benign freckles, ephelis, café-au-lait stains, nervus pilus, seborrheic keratosis and skin chloasm, and tattoos. Fin and superficial vessels are better treated with the Nd: Yag laser 532 nm Qs which causes less pain than other laser types, completing the treatment which may effect the Nd:Yag laser, long pulse.
- Hand piece Erbium Laser at 2.940 nm. Due to the high power and the exclusive guide light, the use of this laser results in the ablation process which is a delicate and uniform exfoliation of the atrophic superficial (5 micron) layer of the skin.
The provided 510(k) summary for the APL MEDICAL SYSTEM does not include any acceptance criteria or a study proving the device meets said criteria.
Instead, the submission relies solely on a demonstration of substantial equivalence to a previously marketed predicate device (MSq(M2) LTD - Lovely System, K042000 and K033946). This type of submission, common for 510(k) clearances, posits that because the new device is sufficiently similar to an already cleared device in terms of design, intended use, and performance characteristics, it is therefore as safe and effective.
Here's a breakdown of why the requested information about acceptance criteria and studies is not present in this document:
- No Acceptance Criteria: The document does not define specific performance metrics or thresholds for the APL MEDICAL SYSTEM to achieve.
- No Studies Demonstrating Performance Against Acceptance Criteria: Since no acceptance criteria are defined, no study is presented to show the device meets them. The document explicitly states:
- "Non-Clinical Performance Data: None"
- "Clinical Performance Data: None"
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this information is not provided in a submission based purely on substantial equivalence without performance data.
Summary of what is available from the document regarding the substantial equivalence argument:
| Information Sought | Response (Based on Provided Text) |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not Applicable: The document does not provide acceptance criteria or performance data for the APL MEDICAL SYSTEM. Its clearance is based on substantial equivalence to a predicate device. |
| 2. Sample size used for the test set and the data provenance | Not Applicable: No test set was used for performance evaluation as no clinical or non-clinical performance data was submitted. The submission relies on demonstrating similarity to a predicate device. |
| 3. Number of experts used to establish the ground truth for the test set and their qualifications | Not Applicable: No test set with ground truth established by experts was used. |
| 4. Adjudication method for the test set | Not Applicable: No test set requiring adjudication was used. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size | Not Applicable: No MRMC comparative effectiveness study was performed. |
| 6. If a standalone (algorithm only) performance study was done | Not Applicable: The APL MEDICAL SYSTEM is a physical laser system, not an algorithm. No standalone performance study was reported. |
| 7. The type of ground truth used | Not Applicable: No ground truth was established as no performance studies were submitted. |
| 8. The sample size for the training set | Not Applicable: This is a physical device, not an AI/ML algorithm that requires a training set. |
| 9. How the ground truth for the training set was established | Not Applicable: This is a physical device, not an AI/ML algorithm that requires a training set and associated ground truth. |
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K 072344
510(k) SUMMARY
| Submitter: | Bios Italia s.r.l.Via Guido Rossa, 10/1220090 Vimodrone (MI) - Italy | |
|---|---|---|
| Contact: | Aldo Casalino | DEC 03 2007 |
| Date Summary Prepared: | June 27, 2007 | |
| Device Trade Name: | APL MEDICAL SYSTEM | |
| Common Name: | Medical Laser System | |
| Classification Name: | Instrument, surgical, powered, laserGEX and FTC21 CFR 878.4810 and 21 CFR 878.4630 | |
| Equivalent Device: | MSq(M2) LTD - Lovely System (K042000 and K033946) | |
| Device Description: | The portable device APL MEDICAL SYSTEM, is a multi-laser and pulsed light system, designated to act on the mostdiffused imperfections of the skin and body. Theequipmentm is conceived as an expandable system for thefield of aesthetic medicine, composed of a modularplatform, containing the entire electronics of the system andthe cooling circuit, and a series of interchangeable handpieces to be connected on the platform, finalized to treatspecific groups of imperfections. A rapid connectionenables the quick and easy replacement of the various handpieces that can be mounted on the modular platform. Thefollowing hand pieces are available: | |
| 1) Hand piece Pulsed Light. With the use of this hand piecethe removal of unwanted hair is extremely quick andefficient, as it is possible to treat large areas (up to 9cm2) using a single pulse or "burst" mode This systemis effective on varius skin types. On this hand piece it ispossible to change easily the guide light, equipped witha specific light filter and to use thus that one mostadequate for the individual photo type. Furthermore, it is |
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possible to conduct a combination of methods to attenuate facial skin imperfections related to small perorbital and labial wrinkles. With the use of guide lights within the spectrum 300-380 nm it is possible to treat psoriasis and vitiligo disease with a specific therapy. This technique has the advantage of acting directly on the concerned area while respecting the surrounding tissues.
-
- Hand piece Nd:Yag Laser at 1064nm, long pulse (ms). With this laser it is possible to treat teleangectasies easyly and quickly with optimal results and without leaving a cicatrix. Furthermore, it is possible to hair removal on small areas with "difficult" skin and hairs.
-
- Hand piece Nd: Yag Laser 1064 and 532 nm Qs (Qswitched), short pulse (ns). This laser is able to selectively destroy melanosomes through cell lysis. The Qs laser is ideal for the treatment of pigmentated lesions and in general for all superficial pigmentations, since its wavelength is well absorbed by the melanin as well as by the haemoglobin. Furthermore, the pulse width makes this type of laser selective with regards to melanosomes -i.e. benign freckles, ephelis, café-au-lait stains, nervus pilus, seborrheic keratosis and skin chloasm, and tattoos. Fin and superficial vessels are better treated with the Nd: Yag laser 532 nm Qs which causes less pain than other laser types, completing the treatment which may effect the Nd:Yag laser, long pulse.
-
- Hand piece Erbium Laser at 2.940 nm. Due to the high power and the exclusive guide light, the use of this laser results in the ablation process which is a delicate and uniform exfoliation of the atrophic superficial (5 micron) layer of the skin.
The APL MEDICAL SYSTEM is indicate for: removal of Intended Use: unwanted hair and to effect stable long-term or permanent hair reduction; laser skin procedures for the treatment of acne scars and wrinkles; incision, excision, ablation, vaporization of soft tissue; non-ablative treatment of facial wrinkles, such as, but not limited to periocular wrinkles and perioral wrinkles: removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions, treatment of capillaries, teleangiectasies and vascular lesions, the treatment of vitiligo and psoriasis.
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| Rationale for SubstancialEquivalence: | The product specification, functionality, indication for use,and treatment parameters of the APL MEDICAL SYSTEMare the same or very similar to the legally marketed laserMSq(M2) LTD - Lovely System Model: Lovely IIHarmony. |
|---|---|
| Both systems have the same indication for use. | |
| Both systems comprise a flashlamp pumped laser rod(Nd:YAG) generating light at a wavelength of 1064 nm,which is subsequently delivered to the patient via an opticalfiber delivery system, and focusing handpiece. | |
| The APL MEDICAL SYSTEM output characteristics(including pulse duration and fluence) are identical, or verysimilar, to those of the predicate device. | |
| Both lasers utilize class IIIA aiming beams. | |
| Both lasers are microprocessor controlled devices. | |
| Both systems utilize an internal closed loop water-air heathexchanger circuit for optimal thermal control of laser cavity | |
| The risks and benefits for the APL MEDICAL SYSTEM arecomparable to those for the predicate device. Therefore, theintroduction of this laser should not raise new questions ofSafety and Effectiveness . |
.
Non-Clinical Performance Data: None
Clinical Performance Data: None
:
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2007
Bios Italia s.r. % Mr. Aldo Casalino General Manager Via Guido Rossa, 10/12 Vinodrone (Milan) MI I-20090 Italy
Re: K072344 Trade/Device Name: APL Medical 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, FTC Dated: November 8, 2007 Received: November 27, 2007
Dear Mr. Casalino:
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. Aldo Casalino
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 H. Mullman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number (if known): K072344
Device Name: APL MEDICAL SYSTEM
Sponsor Name: Bios Italia s.r.l.
Indication for Use:
The APL MEDICAL SYSTEM is a modular multi-laser and multi-use device and are intended for use in aesthetic, cosmetic, and surgical applications.
It is used to treat common imperfections and lesions of skin and body , including:
-
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction
-
- Laser skin treatment procedures for the treatment of:
- Acne scars .
- Wrinkles .
-
- Incision, excision, ablation, vaporization of soft tissue
- The non-ablative treatment of facial wrinkles, such as, but not limited to: 4.
- Periocular wrinkles .
- . Perioral wrinkles
-
- Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
-
- Treatment of capillaries, teleangiectasies and vascular lesions
-
- Treatment of vitiligo and psoriasis
The equipment should only be used under medical supervision.
Do Not Write Below This Line – Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ☑ |
|---|---|
| Over-The-Counter Use | □ |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number: k6723449
§ 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.