(61 days)
041829, K 032205, K 032191
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the hardware and light delivery mechanism.
Yes
The device is indicated for treatment of various medical conditions such as vascular lesions, benign pigmented lesions, and mild to moderate inflammatory acne, which classifies it as a therapeutic device.
No
The device's indicated uses are for treatment (hair removal, lesion treatment, acne treatment), not for diagnosing conditions.
No
The device description explicitly states it consists of hardware components such as a cabinet, power supply, cooling system, microcontroller, umbilical, handpiece, and waveguide, indicating it is a physical device, not software-only.
Based on the provided information, the Apollo Mini-IPL System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Apollo Mini-IPL System Function: The description clearly states that the Apollo Mini-IPL System delivers pulsed light to the skin for various treatments (hair removal, vascular lesions, pigmented lesions, acne). This is a therapeutic or cosmetic device that interacts directly with the body's surface, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes based on laboratory testing.
Therefore, the Apollo Mini-IPL System falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Apollo Mini IPL systems is intended to be used by providing phototherapeutic light for Hair Removal, Permanent hair reduction, Treatment of vascular lesions, Treatment of benign pigmented lesions, Mild to Moderate inflammatory acne. The Apollo Mini-IPL is indicated for use on skin types I-IV.
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)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance Data: None
Results of Clinical Study: None
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.
041829, K 032205, K 032191
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
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 LLC |
| 102 Oxmoor Road Suite 13 | |
| Homewood, 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, laser |
| 79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate Device(s): | NaturaLight System 510(K) 041829. |
| Radiancy Acne System with ClearTouch Light Unit | |
| K 032205 | |
| OmniLight FPL System K 032191 | |
| Description of the Apollo Mini IPL | |
| System: | 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. | |
| Intended use of the Apollo Mini IPL | |
| System: | The Apollo Mini IPL systems is intended to be used by |
| providing phototherapeutic light for Hair Removal, | |
| Permanent hair reduction, Treatment of vascular lesions, | |
| Treatment of benign pigmented lesions, Mild to Moderate | |
| inflammatory acne. The Apollo Mini-IPL is indicated for use | |
| on skin types I-IV. | |
| Performance Data: | None |
| Results of Clinical Study: | None |
| Conclusion: | The Apollo Mini IPL System is substantially equivalent to |
| other existing IPL Systems in commercial distribution for use | |
| in Dermatology and Plastic Surgery. |
1
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.
2
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
3
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