Q-CLEAR
Device Facts
| Record ID | K110370 |
|---|---|
| Device Name | Q-CLEAR |
| Applicant | Light Age, Inc. |
| Product Code | PDZ · General, Plastic Surgery |
| Decision Date | Sep 15, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K110370 · Sep 15, 2011 | Q-CLEAR | Light Age, Inc. | Clinical study of 100 subjects; Postmarket performance data (500,000+ treatments) | The sponsor provided clinical study results to demonstrate the effectiveness of the laser for onychomycosis and cited long-term postmarket usage data to support the safety profile of the device. | Onychomycosis; Postmarket safety; Clinical study |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Clinical study of 100 randomized subjects | Subjects of both genders, including Caucasian, Asian, African American, and Latino, with onychomycosis; Sample Size: 100 | Not applicable for this study | Clearance of dystrophic toenails; patient satisfaction; adverse reactions |
| Postmarket surveillance / real-world usage summary; Follow-up/Duration: 7 years; Study Period: 2003-2011 | General patient population; Sample Size: 500,000+ treatments | Not applicable for this study | Safety and absence of significant patient or operator injury |
Indications for Use
The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the incision, excision, vaporization of soft tissues. The Light Age, Inc. Q-Clear™ Nd: YAG Laser is indicated for the following uses: The 1064nm wavelength is indicated for : 1. Podiatry for incision, excision, vaporization, coagulation of soft tissues including: -Matrixectomy Warts including periungual, subungual, and plantar warts ﺖ Radical nail excision ー -Neuromas The O-Clear™ Laser System is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) 2. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including: Lesions of the skin and subcutancous tissue l Spider veins - Plantar Warts - Periungual and subungual warts l Debridement of decubitus ulcer ー Treatment of keloids - 3. General Dermatology Dark ink tattoo removal ー Treatment of pigmented lesions (particularly Nevus of Ota) l -Removal or lightening of hair Skin resurfacing with or without adjuvant preparation - Treatment of common Nevi - The 532 nm wavelength is indicated for: 1. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including spider veins: 2. General Dermatology Removal of light ink (red, tan, purple, and orange) tattoos 1 Treatment of common nevi ಲ Treatment of café-au-lait spots - Treatment of seborrheic keratoses Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
Device Story
Nd:YAG laser system; emits pulsed 1064nm (infrared) or 532nm (green) light via crystal rod. Operator targets tissue using red aiming beam; energy delivered via handpiece to skin/tissue. Used in clinical settings (dermatology, podiatry, plastic surgery) by trained professionals. System includes main console with control panel, footswitch, and various handpieces. Provides incision, excision, vaporization, and coagulation of soft tissues; temporary increase of clear nail in onychomycosis patients. Clinical benefit: effective clearance of dystrophic toenails and treatment of various dermatological conditions. Output affects clinical decision-making by enabling precise tissue ablation or pigment/vascular lesion targeting.
Clinical Evidence
Prospective study of 100 randomized subjects (diverse demographics) with onychomycosis. Primary endpoint: clearance of dystrophic toenails. Results: 95% of subjects showed significant apparent clearing; average clearance of affected areas 56±7% (98% confidence). No pain or significant adverse reactions reported; 100% patient satisfaction.
Technological Characteristics
Nd:YAG crystal rod lasing medium; flashlamp-pumped solid state. Wavelengths: 1064nm and 532nm (frequency doubled). Output: pulsed, multi-mode. Max power 6W; max energy 200-725mJ/pulse depending on level. Aiming beam: 630-680nm. Electrical: 120/220-240VAC. Compliance: 21 CFR 1040.10/11, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-22. Delivery: non-sterile, reusable handpieces.
Indications for Use
Indicated for patients requiring soft tissue incision, excision, vaporization, or coagulation in podiatry, dermatology, and plastic surgery. Specific conditions include onychomycosis (temporary increase of clear nail), warts, neuromas, keloids, decubitus ulcers, pigmented lesions (e.g., Nevus of Ota, café-au-lait spots, lentigines, ephelides), vascular lesions (e.g., spider veins, telangiectasias, angiomas, hemangiomas, port wine stains), seborrheic keratoses, tattoos, and hair removal/lightening.
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
- Light Age Q-Clear™ Laser (K033259)
- Pinpointe FootLaser™ (K093545 and K093547)
- Cutera GenesisPlus Laser System (K103626)
- Palomar Q-YAG 5™ Nd:YAG Laser System (K061436)
- Family of Altus Medical CoolGlide Aesthetic Lasers (K022226)
Submission Summary (Full Text)
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Light Age, Inc.
## SEP 1 5 2011
# 510(k) Summary
Light Age, Inc. Q-Clear™ Nd:YAG Laser
#### Submittal Information:
Post Approval Contact: Dr. Donald F. Heller, Chief Executive Officer Elizabeth Reddington, Director of Regulatory Affairs Light Age, Inc. 500 Apgar Drive Somerset, NJ 08873 Tel: 732-563-0600 Fax: 732-563-1571
Device Name and Classification:
| 510(k) Number: | K110370 |
|------------------------|------------------------------------|
| Proprietary Name: | Light Age Q-Clear™ Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Class IV Laser Surgical Instrument |
| Classification Panel : | General & Plastic Surgery Devices |
| C.F.R. Section | 878.4810 |
| Device Class: | II |
| Product Code: | GEX |
#### Predicate Devices:
- ♥ Light Age Q-Clear™ Laser [K033259], manufactured by Light Age, Inc., 500 Apgar Drive, Somerset, NJ 08873
- Pinpointe FootLaser™ [K093545 and K093547], manufactured by Pinpointe USA, Inc, 275 . Airpark Boulevard, Suite 100, Chico, CA 95973
- . Cutera GenesisPlus Laser System [K103626], manufactured by Cutera, Inc., 3240 Bayshore Blvd., Brisbane, CA 94005
- Palomar Q-YAG 5™ Nd:YAG Laser System [K061436], manufactured by Palomar Medical . Technologies, Inc. 82 Cambridge Street, Burlington, MA 01803
- . Family of Altus Medical CoolGlide Aesthetic Lasers (K022226), manufactured by Altus Medical, Inc. 821 Cowan Road, Burlingame, CA 94010
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### Description:
The Light Age Q-Clear™ laser has an Nd:YAG crystal rod as a lasing medium. Pulsed energy is emitted at 1064 nanometers in the infrared portion of the spectrum. With the frequency doubler installed, a 532nm beam is emitted. The 532nm emission is visible green light. Energy from the laser is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety fealures in conformance with 21 CFR Part 1040.
The Q-Clear™ Nd:YAG laser system is comprised of the following main components:
- (1) Main Console consists of electrical components including
- a. Control and Display Panel with
- Keyswitch controlling access to the system and mode of operation (off, standby and ready)
- Emergency Stop Button
- Remote Interlock Connector ﻗ
- Footswitch connector ﻥ
- Power Cord connector ರ.
- (2) Footswitch
- (3) Medical grade power cord
- (4) Q-Switched 1064 / 532 nm Treatment Head with Nd:YAG laser rod
- (5) Long Pulsed 1064 nm Treatment Head with Nd:YAG laser rod
- (6) Delivery Devices intended for Non-Contact and contact with intact skin / tissue
- a. Handpieces
- b. Handbiece tips
- (7) Operator and Patient safety glasses and goggles
- (8) Accessories standoffs, water bottle
#### Indications For Use:
The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the incision, excision, vaporization of soft tissues. The Light Age, Inc. Q-Clear™ Nd:YAG Laser is indicated for the following uses:
The 1064nm wavelength is indicated for :
- 1. Podiatry for incision, excision, vaporization, coagulation of soft tissues including:
- Matrixectomy ー
- Warts including periungual, subungual, and plantar warts l
- Radical nail excision -
- Neuromas -
- The Q-Clear™ Laser System is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
- 2. Dermatology and Plastic Surgery for incision, excision, vaporization, vaporization of soft tissues including:
- -Lesions of the skin and subcutaneous tissue
- Spider veins 一
- Plantar Warts ー
- Periungual and subunqual warts l
- Debridement of decubitus ulcer l
- -Treatment of keloids
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3. General Dermatology
- Dark ink tattoo removal ー
- -Treatment of pigmented lesions (particularly Nevus of Ota)
- ﺖ Removal or lightening of hair
- Skin resurfacing with or without adjuvant preparation -
- Treatment of common Nevi ー
The 532 nm wavelength is indicated for:
- 1. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including:
- । Spider veins
- 2. General Dermatology
- Removal of light ink (red, tan, purple, and orange) tattoos l
- Treatment of common nevi l
- Treatment of café-au-lait spots -
- Treatment of seborrheic keratoses -
- Treatment of vascular lesions, including facial and leg veins, telangiectasias, ー
- angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
### Summary of Clinical Tests:
Light Age, Inc.'s study of 100 randomized subjects of both genders, including Caucasian, Asian, African American, and Latino, has demonstrated substantially effective clearance of dystrophic toenails having a clinically apparent diagnosis of onychomychosis. Statistical analysis of results indicates significant apparent clearing in 95% of the subjects with an average clearance of affected areas of 56±7% at 98% level of confidence. The protocol employed was extremely well tolerated by patients, no pain was reported, although some patients reported feeling a low-level sensation on some involved toenails. Reported patient satisfaction was 100%. No significant adverse reactions or responses were observed or reported.
The Q-Clear™ Laser System is indicated for use for the temporary increase of clear nail in patients with onychornycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
#### Performance Standards:
- The Q-Clear™ Nd:YAG Laser System complies with applicable performance standards for light . emitting products as outlined in 21 CFR1040.10 and 21 CFR1040.11.
- The device also conforms to the voluntary electrical equipment standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-22.
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### Summary of Technological Characteristics:
The technological characteristics of the Q-Clear™ Nith the Long Pulse (LP) Head is substantially equivalent to the predicate device, having performance parameters within the latter's characteristic envelope – see table below:
| | Current Submission | | Predicate Device A | Predicate Device B | Predicate Device C |
|------------------------------------|-------------------------------------------------------------------|-----------------------|--------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------|
| Characteristic | Q-Clear™ Nd:YAG | | Pinpointe FootLaser™<br>(K093547) | Family of Altus<br>CoolGlide™ Aesthetic<br>Lasers (K022226) | Palomar Q-YAG 5™<br>Nd:YAG Laser System<br>(K061436) |
| Lasing Medium | Nd:YAG rod | | Nd:YAG rod | Nd:YAG rod | Nd:YAG rod |
| Aiming Beam | 630-680 nm (≤ 2.5mW) | | 630-680 nm (≤ 2.5mW) | Yes | Yes |
| Wavelength | 1064nm | 1064 / 532nm | 1064 nm | 1064 / 532nm | 1064 / 532nm |
| Model | LP | Q-Switched | "6W" Pinpoint Foot Laser | CoolGlide™ | Q-YAG 5™ |
| Maximum Power<br>(Watts) | 6W | 6W | 6W | 14W | 4W |
| Maximum Energy<br>Per Pulse | 200mJ | *400mJ | 200mJ | 7J | 400mJ |
| Maximum Pulse<br>Duration | 100-200 3 - 10 nsec 100-3000 0.1-300msec 3 nsec | | | | |
| Output mode | Pulsed,<br>multi-mode | Pulsed,<br>multi-mode | Pulsed,<br>multi-mode | Pulsed,<br>multi-mode | Pulsed,<br>multi-mode |
| Repetition Rate | 1 - 5 Hz | 1 – 5 Hz,<br>Variable | 5-100 Hz | Single shot, up to 2 Hz | 1-10 Hz |
| Laser Media | Flashlamp -<br>Pumped solid state laser rod | | Flashlamp -<br>Pumped solid state laser<br>rod | Flashlamp -<br>Pumped solid state<br>laser rod | Flashlamp -<br>Pumped solid state laser<br>rod |
| User interface | Push button control panel | | Push button control panel | Push button control<br>panel | Push button control panel |
| User Activation | Footswitch | | Footswitch | Footswitch | Finger or Footswitch |
| Delivery Devices<br>(How supplied) | Non-sterile, reusable, cleanable,<br>sterilizable | | Non-sterile, reusable,<br>cleanable sterilizable | Non-sterile, reusable,<br>cleanable, sterilizable | Non-sterile, reusable,<br>cleanable sterilizable |
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## Light Age, Inc.
## Q-Clear™ Nd:YAG Laser
| Characteristic | Current Submission | Predicate Device A<br>Pinpointe FootLaser™<br>(K093547) | Predicate Device B<br>Family of Altus<br>CoolGlide™ Aesthetic<br>Lasers (K022226) | Predicate Device C<br>Palomar Q-YAG 5™<br>Nd:YAG Laser System<br>(K061436) |
|----------------------------|------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Q-Clear™ Nd:YAG | | | |
| System<br>Dimensions | 10" x 14" x 16" ( H x W x D) | 32" x 13"x 14"(H x W x D) | 12" x 19" x 35"<br>(W x D x H) | 18" (45.7 cm) L x 19"<br>(48.3 cm) H x 17" (43.2<br>cm) D |
| System Weight | 16 Kg (35 lbs) | 17.2 kg (38 lbs) | 61 kg (135 lbs) | Upper Module, 35 lbs.<br>(15.8 kg); Lower Module,<br>35 lbs. (15.8 kg); Arm, <15<br>lbs. (6.8 kg); Handpiece,<br><3 lbs. (1.4 kg) |
| Electrical<br>Requirements | 120/220-240VAC 50/60Hz;<br>10/5A; Single Phase | 90-130 VAC 50/60 Hz<br>200-240 VAC, 50/60 Hz | 110-230V 50/60 Hz | 100 – 240V, 50/60Hz |
* Maximum Energy Per Pulse is set by the levels below:
Level 1 is equivalent to 350 mJ/Pulse. Level 2 is equivalent to 500 mJ/Pulse. Level 3 is equivalent to 600 mJ/Pulse. Level 4 is equivalent to 725 mJ/Pulse.
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### Substantial Equivalence
The reason for this 510(k) is based on new indications for use. Light Age, Inc. is adding new indications for use to our existing Q-Clear™ Nd:YAG laser system that has been cleared and in use since 2003 with no FDA reportable events.
The Light Age Q-Clear™ Nd:YAG Laser is substantially equivalent to the predicate devices listed above (Light Age Q-Clear™ Laser (K033259), Pinpointe FootLaser™ (K093547), Family of Altus CoolGlide™ Aesthetic Lasers (K022226), and the Palomar Q-YAG 5™ Nd:YAG Laser System (K061436)), with the same wavelengths, the same principles of operation, and essentially the same fluence levels. The differences in the specifications between the Q-Clear™ and the predicate device does not raise new questions of safety or efficacy.
#### Safety and Effectiveness:
The Light Age, Inc. Q-Clear™ Nd:YAG Laser System should not raise any concerns regarding its overall safety and effectiveness. In the nearly seven (7) years of use with over 500,000 treatments performed the Q-Clear™ Nd:YAG Laser has been proven to be clinically safe with no reports of significant patient or operator Injury.
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Image /page/6/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 often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2013
Light Age, Inc. % Ms. Elizabeth Reddington Director of Regulatory Affairs 500 Apgar Drive Somerset, New Jersey 08873-1150
Re: K110370
Trade/Device Name: Q-Clear™ Nd:YAG Laser 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: PDZ, GEX Dated: September 09, 2011 Received: September 12, 2011
Dear Ms. Reddington:
This letter corrects our substantially equivalent letter of September 15, 2011.
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
{7}------------------------------------------------
Page 2 - Ms. Elizabeth Reddington
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industrv/default.htm.
> Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
## INDICATIONS FOR USE STATEMENT:
510(K) Number: K110370
Device Name: Q-Clear™ Nd:YAG Laser
Indications for Use:
The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the incision, excision, vaporization of soft tissues. The Light Age, Inc. Q-Clear™ Nd: YAG Laser is indicated for the following uses:
The 1064nm wavelength is indicated for :
- 1. Podiatry for incision, excision, vaporization, coagulation of soft tissues including:
- -Matrixectomy
- Warts including periungual, subungual, and plantar warts ﺖ
- Radical nail excision ー
- -Neuromas
- The O-Clear™ Laser System is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
- 2. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including:
- Lesions of the skin and subcutancous tissue l
- Spider veins -
- Plantar Warts -
- Periungual and subungual warts l
- Debridement of decubitus ulcer ー
- Treatment of keloids -
- 3. General Dermatology
- Dark ink tattoo removal ー
- Treatment of pigmented lesions (particularly Nevus of Ota) l
- -Removal or lightening of hair
- Skin resurfacing with or without adjuvant preparation -
- Treatment of common Nevi -
The 532 nm wavelength is indicated for:
- 1. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including spider veins:
- 2. General Dermatology
- Removal of light ink (red, tan, purple, and orange) tattoos 1
- Treatment of common nevi ಲ
- Treatment of café-au-lait spots -
- Treatment of seborrheic keratoses
Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, (Division Sign-Off) (Division Sign-Off) Division of Surgers and Restorative (P
(Please Do Not Write Below This Line - Continue on Another Page If Needed)
**510(k) Number**
X Prescription Use (Per 21 CFR 801.109)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over the Counter Use _
