(65 days)
Not Found
No
The document describes a laser and IPL system with no mention of AI or ML capabilities. The device description focuses on the hardware and energy delivery mechanisms.
Yes
The device is described as treating various medical conditions or altering the structure or function of the body, such as skin ablation, treatment of wrinkles, treatment of vascular lesions, treatment of benign pigmented lesions, and mild to moderate inflammatory acne.
No
The description explicitly states its intended uses are for skin ablation, dermabrasion, treatment of wrinkles, coagulation, vaporization, ablation, cutting of soft tissue, hair removal, treatment of vascular lesions, benign pigmented lesions, and mild to moderate inflammatory acne. These are all therapeutic or aesthetic treatments, not diagnostic purposes.
No
The device description clearly outlines a system with a console, handpieces (Er:YAG laser and IPL), and a footswitch, indicating significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described are for direct treatment of the skin (ablation, dermabrasion, wrinkle treatment, coagulation, vaporization, cutting, hair removal, treatment of vascular and pigmented lesions, acne). These are all therapeutic or aesthetic procedures performed directly on the patient's body.
- Device Description: The device is a laser and IPL system designed to deliver energy to the skin.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is clearly intended for direct application of energy to the patient's skin for therapeutic and aesthetic purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Er:YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coaqulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in 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 (510 nm filter) Mild to Moderate inflammatory acne (450nm filter)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er: YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy produced within the device is delivered to the tissue in a wavelength of 2940nm. The Intense Pulsed Light wavelengths are 450nm - 1200nm The user activates laser and IPL emission by means of a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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.
K)032599, K)081219
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 Apex Er:YAG / IPL System
K 110304
APR - 8 2011
This 510(K) Summary of safety and effectiveness for the Apex Er:YAG / 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: | 105 Citation Court |
| Birmingham, AL 35209 |
| Contact Person: | Mark Rohrer |
|---|---|
| Telephone: | 205-290-8251 - phone |
| Email: | ssmed@bellsouth.net |
Preparation Date:
January 31, 2011
Apex Er:YAG / IPL System
79-GEX, 21 CFR 878-48
Device Trade Name:
Common Name: Classification Name:
Legally Marketed Predicate Device:
Description of the Apex Er:YAG / IPL System:
Intended use of the Apex Er:YAG / IPL System:
MLT Erbium:YAG Laser System (K)032599 Apollo Mini IPL System (K)081219
ER:YAG laser and Intense Pulsed Light
Instrument, Surgical, Powered, laser
The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er: YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy produced within the device is delivered to the tissue in a wavelength of 2940nm. The Intense Pulsed Light wavelengths are 450nm - 1200nm The user activates laser and IPL emission by means of a footswitch.
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in 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 (510 nm filter), Mild to Moderate inflammatory acne (450nm filter)
1
Attachment 5 510(K) Summary Apex Er:YAG / IPL System
Performance Data: None
Results of Clinical Study: None
Summary of Technological Characteristics:
| | Sandstone Medical
Technologies LLC Apex
Er:YAG / IPL System | Sandstone Medical
Technologies LLC Apollo
Mini IPL System |
|---------------|-------------------------------------------------------------------|-----------------------------------------------------------------|
| Light Source | Pulsed Incoherent Light | Pulsed Incoherent Light |
| Max Fluence | Up to 35J/cm² | Up to 35J/cm² |
| Wavelength | 450 - 1200 nm | 450 - 1200 nm |
| Spot Size | 35 x 15 mm2 | 35 x 15 mm2 |
| Pulse Width | Up to 200ms | Up to 200ms |
| Beam Delivery | Light Guide | Light Guide |
| Stem | | |
| | Sandstone Medical
Technologies LLC Apex
Er:YAG / IPL System | Sandstone Medical
Technologies LLC
Er:YAG Laser |
|-----------------|-------------------------------------------------------------------|-------------------------------------------------------|
| Wavelength | 2940nm | 2940nm |
| Max Power | 2.4 W | 2.4 W |
| Max Fluence | 5J/cm2 | 5J/cm2 |
| Pulse Width | 300 $\mu$ s | 300 $\mu$ s |
| Repetition Rate | Up to 10 pulse per
second | Up to 10 pulse per
second |
| Spot Size | 1.5mm, 3mm, 6mm,
9mm | 1.5mm, 3mm, 6mm, 9mm |
Conclusion:
The Apex Er:YAG / IPL is substantially equivalent to the MLT Erbium:YAG Laser System (K)032599 and to the Apollo Mini IPL System (K)081219. The Apex Er: YAG / IPL is substantially equivalent in terms of indication for use and technology based on technical characteristics.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its head turned to the right, symbolizing vigilance and strength. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Sandstone Medical Technologies LLC % Mr. Mark Rohrer 105 Citation Court Birmingham, Alabama 35209
APR - 8 2011
Re: K110304
Trade/Device Name: Apex ER:YAG / 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: Class II Product Code: GEX Dated: January 31, 2011
Received: February 03, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Mark Rohrer
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aty B. Rta
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K Reading 110304 510(k) Number (if known):
Apex Er:YAG / IPL System Device Name:
The Er:YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coaqulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in 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 (510 nm 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
|--|--|
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number 110304