(219 days)
Not Found
No
The provided 510(k) summary describes a laser system for soft tissue and lesion treatment. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML capabilities. The device description focuses on the physical components and laser technology.
Yes
The device is described as a laser system intended for medical uses such as incision, excision, vaporization of soft tissues, removal of various lesions and tattoos, treatment of spider veins, and temporary increase of clear nail in patients with onychomycosis. These applications are for treating or diagnosing disease, or restoring, correcting or modifying physiological structures/functions, which falls under the definition of a therapeutic device.
No
The device is a therapeutic laser system used for the incision, excision, vaporization, and coagulation of soft tissues, and for the temporary increase of clear nail in patients with onychomycosis, as well as for various dermatological treatments. It is not used for diagnosis.
No
The device description clearly outlines multiple hardware components including a main console, footswitch, power cord, treatment heads, delivery devices (handpieces and tips), and safety glasses/goggles. This is a hardware-based laser system with associated software for control and display, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is a therapeutic device that uses laser energy to directly treat soft tissues, skin, and nails. It is used for procedures like incision, excision, vaporization, and coagulation.
- Intended Use: The intended uses listed are all direct treatments of the patient's body, not analysis of samples taken from the body.
- Device Description: The description details the laser components and delivery system, which are consistent with a therapeutic laser, not an IVD.
Therefore, the Light Age, Inc. Q-Clear™ Nd:YAG Laser System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 :
- Podiatry for incision, excision, vaporization, coagulation of soft tissues including:
- Matrixectomy
- Warts including periungual, subungual, and plantar warts
- 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.)
- Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including:
- Lesions of the skin and subcutaneous tissue
- Spider veins
- Plantar Warts
- Periungual and subungual warts
- Debridement of decubitus ulcer
- Treatment of keloids
- General Dermatology
- Dark ink tattoo removal
- Treatment of pigmented lesions (particularly Nevus of Ota)
- Removal or lightening of hair
- Skin resurfacing with or without adjuvant preparation
- Treatment of common Nevi
The 532 nm wavelength is indicated for:
- Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including spider veins:
- General Dermatology
- Removal of light ink (red, tan, purple, and orange) tattoos
- Treatment of common nevi
- 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)
Product codes (comma separated list FDA assigned to the subject device)
GEX, PDZ
Device 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
- Footswitch connector
- Power Cord connector
- a. Control and Display Panel with
- (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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, skin, subcutaneous tissue, nail, toenails
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General and plastic surgery, dermatology, podiatry
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Significant apparent clearing in 95% of subjects with an average clearance of affected areas of 56±7% at 98% level of confidence. Reported patient satisfaction was 100%.
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.
K033259, K093545, K093547, K103626, K061436, K022226
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
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
1
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.
- a. Control and Display Panel with
- (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 :
-
- 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.)
-
- 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
2
- 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:
-
- Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including:
- । Spider veins
-
- 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.
3
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™ | |||
| (K093547) | Family of Altus | ||||
| CoolGlide™ Aesthetic | |||||
| Lasers (K022226) | Palomar Q-YAG 5™ | ||||
| Nd:YAG Laser System | |||||
| (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 | |||||
| (Watts) | 6W | 6W | 6W | 14W | 4W |
| Maximum Energy | |||||
| Per Pulse | 200mJ | *400mJ | 200mJ | 7J | 400mJ |
| Maximum Pulse | |||||
| Duration | 100-200 3 - 10 nsec 100-3000 0.1-300msec 3 nsec | ||||
| Output mode | Pulsed, | ||||
| multi-mode | Pulsed, | ||||
| multi-mode | Pulsed, | ||||
| multi-mode | Pulsed, | ||||
| multi-mode | Pulsed, | ||||
| multi-mode | |||||
| Repetition Rate | 1 - 5 Hz | 1 – 5 Hz, | |||
| Variable | 5-100 Hz | Single shot, up to 2 Hz | 1-10 Hz | ||
| Laser Media | Flashlamp - | ||||
| Pumped solid state laser rod | Flashlamp - | ||||
| Pumped solid state laser | |||||
| rod | Flashlamp - | ||||
| Pumped solid state | |||||
| laser rod | Flashlamp - | ||||
| Pumped solid state laser | |||||
| rod | |||||
| User interface | Push button control panel | Push button control panel | Push button control | ||
| panel | Push button control panel | ||||
| User Activation | Footswitch | Footswitch | Footswitch | Finger or Footswitch | |
| Delivery Devices | |||||
| (How supplied) | Non-sterile, reusable, cleanable, | ||||
| sterilizable | Non-sterile, reusable, | ||||
| cleanable sterilizable | Non-sterile, reusable, | ||||
| cleanable, sterilizable | Non-sterile, reusable, | ||||
| cleanable sterilizable |
4
Light Age, Inc.
Q-Clear™ Nd:YAG Laser
| Characteristic | Current Submission | Predicate Device A
Pinpointe FootLaser™
(K093547) | Predicate Device B
Family of Altus
CoolGlide™ Aesthetic
Lasers (K022226) | Predicate Device C
Palomar Q-YAG 5™
Nd:YAG Laser System
(K061436) |
|----------------------------|------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Q-Clear™ Nd:YAG | | | |
| System
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"
(W x D x H) | 18" (45.7 cm) L x 19"
(48.3 cm) H x 17" (43.2
cm) D |
| System Weight | 16 Kg (35 lbs) | 17.2 kg (38 lbs) | 61 kg (135 lbs) | Upper Module, 35 lbs.
(15.8 kg); Lower Module,
35 lbs. (15.8 kg); Arm, 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 :
-
- 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.)
-
- 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 -
-
- 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:
-
- Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including spider veins:
-
- 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 _