(108 days)
The Tri-Beam Nd:YAG Laser System in indicated for: - the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):
-Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
-Removal of Epidermal Pigmented Lesions
-Removal of Minor Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Caff-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
The E-Beam Nd:YAG Laser System is a O-Switch laser with wavelengths of 1064nm and 532nm. Optional Dye attachments to the handpiece add additional wavelengths of 585nm and 650nm. This system consists of main body, color touch screen, articulated arm hand-piece and Foot switch.
The E-Beam Nd:YAG Laser System can also be used in a long pulse mode.
Here's a breakdown of the acceptance criteria and the study information for the E-Beam Nd:YAG Laser System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this 510(k) summary does not provide explicit acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for clinical outcomes. Instead, the "acceptance criteria" are implied through the direct comparison of technical specifications to a predicate device, aiming for substantial equivalence. The reported device "performance" is, therefore, the matching of these technical specs to the predicate.
| Feature | Predicate Device (Lutronic Spectra Laser System K113588) | E-Beam Nd:YAG Laser System (Subject Device) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Q-Switch Laser | ||||
| Laser Medium | Nd:YAG | Nd:YAG | Match Predicate | Nd:YAG |
| Wavelengths | 1064nm / 532nm (Option: 585nm, 650nm) | 1064nm / 532nm (Option: 585nm, 650nm) | Match Predicate | Match Predicate |
| Operating Mode | Q-Switched | Q-Switched | Match Predicate | Q-Switched |
| Beam Profile | Top Hat Mode | Top Hat Mode | Match Predicate | Top Hat Mode |
| Pulse Energy (1064nm) | 1200mJ | 1200mJ | Match Predicate | 1200mJ |
| Pulse Energy (532nm) | 400mJ | 400mJ | Match Predicate | 400mJ |
| Pulse Energy (585nm) | 250mJ | 250mJ | Match Predicate | 250mJ |
| Pulse Energy (650nm) | 150mJ | 150mJ | Match Predicate | 150mJ |
| Pulse Width | 5ns - 10ns | 5ns - 10ns | Match Predicate | 5ns - 10ns |
| Spot Size (1064nm) | 3,4,5,6,7,8mm (Optional: 1,2,3,4,6,7,mm) | 2-8mm (Collimated: 6mm) | Comparable or broader range | 2-8mm (Collimated: 6mm) |
| Spot Size (532nm) | N/A (listed as blank in predicate table) | 6.9mm (listed as blank in predicate table) | Within accepted range for application | 6.9mm |
| Spot Size (585nm) | 2mm | 2mm | Match Predicate | 2mm |
| Spot Size (650nm) | 2mm | 2mm | Match Predicate | 2mm |
| Pulse Duration (1064nm) | Single, 1,2,5,10 Hz | Single, 1,2,5,10 Hz | Match Predicate | Single, 1,2,5,10 Hz |
| Pulse Duration (532nm) | Single, 1,2,4,5 Hz | Single, 1,2,4,5Hz | Match Predicate | Single, 1,2,4,5Hz |
| Pulse Duration (585nm) | Single, 1,2,4,5 Hz | Single, 1,2,4,5 Hz | Match Predicate | Single, 1,2,4,5 Hz |
| Pulse Duration (650nm) | Single, 1 and 2Hz | Single, 1 and 2Hz | Match Predicate | Single, 1 and 2Hz |
| Beam Delivery | Articulated Arm | Articulated Arm | Match Predicate | Articulated Arm |
| Aiming Beam | Diode 655nm (Red) 1mW | Diode 655nm (Red) 1mW | Match Predicate | Diode 655nm (Red) 1mW |
| Long Pulse Nd:YAG | ||||
| Laser Medium | Nd:YAG | Nd:YAG | Match Predicate | Nd:YAG |
| Wavelengths | 1064nm | 1064nm | Match Predicate | 1064nm |
| Operating Mode | Long Pulse | Long Pulse | Match Predicate | Long Pulse |
| Beam Profile | Top Hat Mode | Top Hat Mode | Match Predicate | Top Hat Mode |
| Pulse Energy | 1500mJ | 1500mJ | Match Predicate | 1500mJ |
| Pulse Width | 300us | 300us | Match Predicate | 300us |
| Spot Size | 3,4,5,6,7,8mm (Optional: 1,2,3,4,6,7,mm) | 2-8mm (Collimated 6mm) | Comparable or broader range | 2-8mm (Collimated 6mm) |
| Pulse Duration | Single, 1,2,5,10 Hz | Single, 1,2,5,10 Hz | Match Predicate | Single, 1,2,5,10 Hz |
| Optical Deliver | Articulated Arm | Articulated Arm | Match Predicate | Articulated Arm |
| Aiming Beam | Diode 655nm (Red) 1mW | Diode 655nm (Red) 1mW | Match Predicate | Diode 655nm (Red) 1mW |
2. Sample Size Used for the Test Set and Data Provenance
- The document explicitly states "None" for "Performance Data: Results of Clinical Study".
- Therefore, there is no test set sample size and no data provenance (country of origin, retrospective or prospective) for a clinical study. The submission relies solely on technical comparison for substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Since no clinical study was performed, there was no ground truth established by experts for a test set.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical study or test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a laser device, not an AI diagnostic or assistive device that would involve human "readers" or an "effect size of human improvement with AI." The document explicitly states "None" for clinical study results.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (laser system), not an algorithm or AI. The concept of "standalone performance" in this context refers to the device's technical specifications and intended functionality, which were evaluated through direct comparison to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the purpose of this 510(k) submission, the "ground truth" for the device's performance is established by its technical specifications directly matching or being functionally equivalent to the technical specifications of the legally marketed predicate device (Lutronic Spectra Laser System K113588). No clinical ground truth (e.g., pathology, outcomes data) based on human subjects was used.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned or implied.
{0}------------------------------------------------
K 122922
Attachment 5 510(K) Summary E-Beam Nd:YAG Laser System
JAN 1 0 2013
This 510(K) Summary of safety and effectiveness for the E-Beam Nd:YAG Laser 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:
Eclipse Aesthetics, LLC
Address:
13988 Diplomat Drive Suite 160 Dallas, TX 75234
Contact Person:
Telephone: Fax: Email:
Preparation Date:
Device Trade Name:
Common Name:
Classification Name:
Legally Marketed Predicate Device:
Description of the E-Beam Nd:YAG Laser System:
Intended use of the E-Beam Nd:YAG Laser System:
Mr. Tom O'Brien
972-380-2911 - phone 972-380-2953 - fax tobrien@eclipsemed.com
September 12, 2012
E-Beam Nd: YAG Laser System
Nd:YAG Q-Switch Laser
Instrument. Surgical, Powered, laser 79-GEX, 21 CFR 878-48
Lutronic Spectra Laser System K113588
The E-Beam Nd:YAG Laser System is a O-Switch laser with wavelengths of 1064nm and 532nm. Optional Dye attachments to the handpiece add additional wavelengths of 585nm and 650nm. This system consists of main body, color touch screen, articulated arm hand-piece and Foot switch.
The E-Beam Nd:YAG Laser System can also be used in a long pulse mode.
The E-Beam Nd:YAG Laser System in indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coaqulation and hemostasis.
532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dve handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky . blue, green)
- . Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not . limited to telangiectasias
- . Treatment of Lentigines
- Treatment of Cafe-Au-Lait .
- Treatment of Seborrheic Keratoses ●
1 of 3
{1}------------------------------------------------
Attachment 5 510(K) Summary E-Beam Nd:YAG Laser System
- Treatment of Post Inflammatory Hyper-Pigmentation .
- Treatment of Becker's Nevi, Freckles and Nevi Spilus .
1064nm Wavelength:
- Tattoo removal: dark ink (black, blue and brown) .
- Removal of Nevus of Ota .
- Removal or lightening of unwanted hair with or without . adjuvant preparation.
- Treatment of Common Nevi ●
- Skin resurfacing procedures for the treatment of acne . scars and wrinkle
Performance Data: Results of Clinical Study: Conclusion:
None None
None
The E-Beam Nd:YAG Laser System is substantially equivalent to the previously cleared predicate devices that are currently in commercial distribution.
Technical Comparison for the Q-Switch Laser
| Feature | Wavelength | E-Beam(Subject of this submission) | Spectra (K113588)(Predicate Device) |
|---|---|---|---|
| Laser Medium | Nd:YAG | Nd: YAG | |
| Wavelengths | 1064nm / 532nm(Option: 585nm, 650nm) | 1064nm / 532nm(Option: 585nm, 650nm) | |
| Operating Mode | Q-Switched | Q-Switched | |
| Beam Profile | Top Hat Mode | Top Hat Mode | |
| Pulse Energy | 1064nm | 1200mJ | 1200mJ |
| 532nm | 400mJ | 400mJ | |
| 585nm | 250 mJ | 250mJ | |
| 650nm | 150mJ | 150mJ | |
| Pulse Width | 5ns - 10ns | 5ns - 10ns | |
| Spot Size | 1064nm | 2-8mmCollimated: 6mm | 3,4,5,6,7,8mmOptional: 1,2,3,4,6,7,mm |
| 532nm | 6.9mm | ||
| 585nm | 2mm | ||
| 650nm | 2mm | 2mm | |
| Pulse Duration | 1064nm | Single, 1,2,5,10 Hz | Single, 1,2,5,10 Hz |
| 532nm | Single, 1,2,4,5Hz | Single, 1,2,4,5,Hz | |
| 585nm | Single, 1,2,4,5 Hz | Single, 1,2,4,5 Hz | |
| 650nm | Single, 1 and 2Hz | Single, 1 and 2Hz | |
| Beam Delivery | Articulated Arm | Articulated Arm | |
| Aiming Beam | Diode 655nm (Red) 1mW | Diode 655nm (Red) 1mW |
{2}------------------------------------------------
Attachment 5 510(K) Summary E-Beam Nd:YAG Laser System
Technical Comparison for the Long Pulse Nd:YAG
.
i
| Feature | E-Beam(Subject of this submission) | Spectra (K113588)(Predicate Device) |
|---|---|---|
| Laser Medium | Nd:YAG | Nd:YAG |
| Wavelengths | 1064nm | 1064nm |
| Operating Mode | Long Pulse | Long Pulse |
| Beam Profile | Top Hat Mode | Top Hat Mode |
| Pulse Energy | 1500mJ | 1500mJ |
| Pulse Width | 300us | 300us |
| Spot Size | 2-8mmCollimated 6mm | 3,4,5,6,7,8mmOptional: 1,2,3,4,6,7,mm |
| Pulse Duration | Single, 1,2,5,10 Hz | Single, 1,2,5,10 Hz |
| Optical Deliver | Articulated Arm | Articulated Arm |
| Aiming Beam | Diode 655nm (Red) 1mW | Diode 655nm (Red) 1mW |
Conclusion:
The E-Beam Nd:YAG Laser System is substantially equivalent to the previously cleared predicate devices that are currently in commercial distribution.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 10, 2013
Eclipse Aesthetics, LLC % Mr. Tom O'Brien Chief Executive Officer 13998 Diplomat Drive Dallas, Texas 75234
Re: K122922
Trade/Device Name: Tri-Beam Nd: YAG Laser 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: December 05, 2012 Received: December 11, 2012
Dear Ms. O'Brien:
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 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
{4}------------------------------------------------
Page 2 - Mr. Tom O'Brien
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/ReportaProblem/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.
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K122922
Device Name: Tri-Beam Nd:YAG Laser System
Indications for Use:
The Tri-Beam Nd:YAG Laser System in indicated for: - the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):
-Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
-Removal of Epidermal Pigmented Lesions
-Removal of Minor Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Caff-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
AND/OR Prescription Use xx (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil R Ogden 2013.01.04 1'4:51:12 -05'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number _ K122922
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.