(61 days)
The Apollo Mini-IPL System is indicated for use skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter), Permanent hair reduction (650nm filter), Treatment of vascular lesions (510nm filter), Treatment of benign pigmented lesions (510nm filter), Mild to Moderate inflammatory acne (450nm filter).
The Apollo Mini IPL System delivers pulsed light at wavelengths starting at 450-1200nm nanometers. The device consists of the cabinet, which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.
The provided text is a 510(k) Summary for the Apollo Mini IPL System. This document outlines the device's intended use and claims substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.
The "Performance Data" and "Results of Clinical Study" sections explicitly state "None." This means that Sandstone Medical Technologies, LLC did not submit performance data or clinical study results with their 510(k) application to demonstrate the Apollo Mini IPL System met specific acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device's performance based on the input text.
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Attachment 5 510(K) Summary Apollo Mini IPL System
JUN 3 0 2008
This 510(K) Summary of safety and effectiveness for the Apollo Mini IPL System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Sandstone Medical Technologies, LLC |
|---|---|
| Address: | Sandstone Medical Technologies LLC102 Oxmoor Road Suite 13Homewood, AL 35209 |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 1-205-290-8251- Phone |
| Preparation Date: | April 15, 2008 |
| Device Trade Name: | Apollo Mini IPL System |
| Common Name: | Intense Pulsed Light |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device(s): | NaturaLight System 510(K) 041829. |
| Radiancy Acne System with ClearTouch Light UnitK 032205 | |
| OmniLight FPL System K 032191 | |
| Description of the Apollo Mini IPLSystem: | The Apollo Mini IPL System delivers pulsed light atwavelengths starting at 450-1200nm nanometers. Thedevice consists of the cabinet, which houses the powersupply, the cooling system and the microcontroller, theumbilical to the handpiece, and the handpiece, which housesthe waveguide. |
| Intended use of the Apollo Mini IPLSystem: | The Apollo Mini IPL systems is intended to be used byproviding phototherapeutic light for Hair Removal,Permanent hair reduction, Treatment of vascular lesions,Treatment of benign pigmented lesions, Mild to Moderateinflammatory acne. The Apollo Mini-IPL is indicated for useon skin types I-IV. |
| Performance Data: | None |
| Results of Clinical Study: | None |
| Conclusion: | The Apollo Mini IPL System is substantially equivalent toother existing IPL Systems in commercial distribution for usein Dermatology and Plastic Surgery. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2008
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 102 Oxmoor Road, Suite 13 Homewood, Alabama 35209
Re: K081219
Trade/Device Name: Sandstone Medical Technologies LLC Apollo Mini IPL 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: June 11, 2008 Received: June 18, 2008
Dear Mr. Rohrer:
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 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.
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Page 2 – Mr. Mark Rohrer
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. Milliman
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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Indications for Use
510(k) Number (if known): K Pending
Device Name:
Sandstone Medical Technologies LLC Apollo Mini IPL System
The Apollo Mini-IPL System is indicated for use skin types I-IV according to the Fitzpatrick Scale for the following indications:
Hair Removal (650nm filter)
Permanent hair reduction (650nm filter)
Treatment of vascular lesions (510nm filter)
Treatment of benign pigmented lesions (510nm filter)
Mild to Moderate inflammatory acne (450nm filter)
Prescription Use XX (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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
1681219 510(k) Number
§ 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.