(122 days)
The Peterio Universal Laser Scanning Handpiece is intended to be used as an accessory to a compatible non-ablative 1064nm laser and for its legally marketed, dermatological indications including: Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin; Coagulation and hemostasis of sub-surface vascular lesions.
The Peterio™ Universal Laser Scanning Handpiece is an accessory for a legally marketed, compatible laser system. It is hand held device which attaches to the distal end of the laser system and delivers rapid scanning of the laser beam over a predetermined surface area. The Peterio has been designed for delivering the energy fluence equivalent to that of legally marketed compatible lasers, to a confined volume at a selectable tissue depth, while at the same time the Peterio exposes the tissue surface to less than 10% of the fluence of such lasers.
The provided 510(k) summary for the Peterio™ Universal Laser Scanning Handpiece (K073048) does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) summary focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It describes the device, its intended use, and compares it to predicate devices, stating that it "is substantially equivalent to its predicate devices in that it is an accessory to a legally marketed laser system and scans the laser beam with rotating mirrors." It also mentions "same basic intended use."
The document does not include:
- A table of acceptance criteria or reported device performance.
- Details on sample sizes for test sets or data provenance.
- Information on ground truth establishment (number/qualifications of experts, adjudication methods).
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance data.
- Details on the type of ground truth used (e.g., pathology, outcomes data).
- Information regarding the training set size or how its ground truth was established.
This is typical for a 510(k) submission where substantial equivalence is primarily based on comparison to existing legally marketed devices, rather than a de novo demonstration of safety and effectiveness through extensive clinical trials with specific performance metrics. The focus is on demonstrating that the new device does not raise new questions of safety and effectiveness compared to its predicates.
{0}------------------------------------------------
50 28 2
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
- Submitter's 1. (a) Alex Rapoport, CEO Address: Arlozorov 41a. Rishon Le Zion, 75214 lsrael 1. (b) Manufacturer Scilex. Ltd. Address: Arlozorov 41a Rishon Le Zion 75214, Israel Mfg. Phone: 972-3-950-6949 Contact Person: Alex Rapoport, CEO Date: October 25, 2007 2. Device & Laser Handpiece Accessory System (Class 2), Product Code GEX, Classification 21 CFR 878.4810 - Tradename of device: Peterio™ Universal Laser Name: Scanning Handpiece 3. Predicate Device: DioScan Scanning Handpiece (K990014) MedArt 455/910 Series Scanner (K984339) Hexascan Handpiece (K901008) 4. Description: The Peterio™ Universal Laser Scanning Handpiece is an accessory for a legally marketed, compatible laser system. It is hand held device which attaches to the distal end of the laser system and delivers rapid scanning of the laser beam over a predetermined surface area. The Peterio has been designed for delivering the energy fluence equivalent to that of legally marketed compatible lasers, to a confined volume at a selectable tissue depth, while at the same time the Peterio exposes the tissue surface to less than 10% of the fluence of such lasers. 5. Intended Use: The Peterio™ Universal Laser Scanning Handpiece is intended to be used as an accessory to a compatible non-ablative 1064 nm laser and for its legally marketed, dermatological indications including: Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin; Coagulation and hemostasis of subsurface vascular lesions. ી. Comparison of With respect to technology, the Peterio ™ Universal Laser Scanning Technological Handpiece is substantially equivalent to its predicate devices in that it is an Characteristics: accessory to a legally marketed laser system and scans the laser beam with rotating mirrors. It also has the same basic intended use as its predicate devices.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right. The profiles are depicted in a flowing, abstract manner.
Public Health Service
FEB 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scilex, Ltd. % Alex Rapoport CEO Arlozorov 41a Rishon Le Zion 75214, Israel
Re: K073048
Trade/Device Name: Peterio" Universal Laser Scanning Handpiece 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 15, 2007 Received: October 29, 2007
Dear Alex Rapoport:
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. Iisting 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
{2}------------------------------------------------
Page 2 - Alex Rapoport
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 vours.
Mark N Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K073048
Device Name: Peterio™ Universal Laser Scanning Handpiece
Indications For Use: The Peterio Universal Laser Scanning Handpiece is intended to be used as an accessory to a compatible non-ablative 1064nm laser and for its legally marketed, dermatological indications including: Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin; Coagulation and hemostasis of sub-surface vascular lesions.
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)
Mark N Millenson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K073048
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.