APEX ER. YAG / IPL SYSTEM
Device Facts
| Record ID | K110304 |
|---|---|
| Device Name | APEX ER. YAG / IPL SYSTEM |
| Applicant | Sandstone Medical Technologies, LLC |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Apr 8, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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)
Device Story
Apex Er:YAG / IPL System is a console-based device with two interchangeable handpieces: an Er:YAG laser and an Intense Pulsed Light (IPL) source. Facility power supplies the console; user activates emission via footswitch. Er:YAG handpiece delivers 2940nm laser energy for superficial skin ablation, dermabrasion, wrinkle treatment, and soft tissue surgery. IPL handpiece delivers 450-1200nm pulsed incoherent light for hair removal, vascular/pigmented lesion treatment, and acne management. Used in clinical settings by physicians/trained practitioners. Output affects clinical decision-making by enabling targeted dermatological and aesthetic procedures. Benefits include precise tissue management and non-invasive skin treatments.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Console-based system with interchangeable handpieces. Er:YAG laser: 2940nm wavelength, 2.4W max power, 5J/cm2 max fluence, 300μs pulse width, 10Hz repetition rate. IPL: 450-1200nm wavelength, 35J/cm2 max fluence, 200ms max pulse width, light guide delivery. Electrical power source. No software algorithm details provided.
Indications for Use
Indicated for skin types I-IV (Fitzpatrick Scale) for hair removal, permanent hair reduction, treatment of vascular/benign pigmented lesions, and mild-to-moderate inflammatory acne. Also indicated for skin ablation, dermabrasion, wrinkle treatment, and soft tissue coagulation, vaporization, ablation, or cutting in dermatology and plastic/aesthetic surgery.
Regulatory Classification
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.
Predicate Devices
- MLT Erbium:YAG Laser System (K032599)
- Apollo Mini IPL System (K081219)
Related Devices
- K081541 — DERMABLATE EFFECT · Asclepion Laser Technologies GmbH · Feb 23, 2009
- K152714 — Quanta Forte · Quanta System Spa · Dec 21, 2015
- K142860 — Lumenis M22 System · Lumenis, Ltd. · Jan 21, 2015
- K081408 — ELLIPSE MULTIFLEX · Ellipse A/S · Oct 17, 2008
- K080006 — AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE · Cynosure, Inc. · Feb 28, 2008
Submission Summary (Full Text)
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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<br>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)
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## Attachment 5 510(K) Summary Apex Er:YAG / IPL System
Performance Data: None
Results of Clinical Study: None
Summary of Technological Characteristics:
| | Sandstone Medical<br>Technologies LLC Apex<br>Er:YAG / IPL System | Sandstone Medical<br>Technologies LLC Apollo<br>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<br>Technologies LLC Apex<br>Er:YAG / IPL System | Sandstone Medical<br>Technologies LLC<br>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<br>second | Up to 10 pulse per<br>second |
| Spot Size | 1.5mm, 3mm, 6mm,<br>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.
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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
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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
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## 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
