Lumenis Smart532 Laser System
Device Facts
| Record ID | K151109 |
|---|---|
| Device Name | Lumenis Smart532 Laser System |
| Applicant | Lumenis, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Oct 30, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows: Ophthalmology Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG) Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG) Ear, Nose and Throat (ENT) Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic procedures Dermatology Pigmented lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases Cutaneous lesions Flat warts Dermatosis Papulosa Nigra Dentistry Frenectomy Treatment of oral mucous cyst Treatment of benign vascular lesions: Capillary hemangioma Hemorrhagic hereditary telangiectasia Capillary/cavernous hemangiomas Lymphangioma AV malformation of the tongue Hermaniolymphangiomas Photocoagulation of superficial vessels Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy: Operative procedures Crown and bridge, gingival reduction Crown lengthening Hyperplasia (Drug, irritation, Epulus, ... ) Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct): Hemostasis of donor site Hemostasis of graft site Vestibuloplasty Soften Gutta Percha Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening
Device Story
Dual-port, solid-state, frequency-doubled, green Nd:GdVO4 surgical laser; emits 532nm wavelength for photothermolysis/photocoagulation of soft tissue. Used in ophthalmology, ENT, dermatology, and dentistry. Operated by clinicians in clinical settings. System includes delivery accessories: slit lamps, laser indirect ophthalmoscopes, and various probes. Features SmartPulse energy delivery (train of brief pulses) for specific ophthalmic indications and CW (continuous wave) for all indications. Clinician selects parameters via touchscreen interface; output provides precise tissue coagulation, vaporization, or hemostasis. Benefits include targeted tissue management with reduced thermal damage compared to traditional methods.
Clinical Evidence
Bench testing only. Includes electrical safety and EMC testing per IEC 60601 3rd Edition series and side-by-side comparative performance assessment against the primary predicate. Verification and validation protocols confirmed design specifications were met.
Technological Characteristics
Diode-pumped solid-state (DPSS) frequency-doubled laser; 532nm wavelength; 50-2,500mW power output. Aiming beam: 635nm diode. Modes: CW, Single Pulse, SmartPulse. Interface: Color touchscreen. Electrical: 100-240 VAC. Accessories: Slit lamps, LIO, endo-ocular/endo-oto probes. Compliance: IEC 60601 series.
Indications for Use
Indicated for patients requiring ophthalmic, ENT, dermatologic, or dental laser procedures, including treatment of diabetic retinopathy, glaucoma, vascular/pigmented lesions, and various soft tissue dental/ENT surgeries.
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
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/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 around the symbol in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Lumenis Incorporated Mr. Rick Gaykowski Global Vice President, Regulatory Affairs & Quality Systems 1870 South Milestone Drive Salt Lake City, Utah 84101
Re: K151109 Trade/Device Name: Lumenis® Smart532™ Laser System and accessories 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: August 20, 2015 Received: August 27, 2015
Dear Mr. Gaykowski:
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 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice
{1}------------------------------------------------
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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
For Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K151109
Device Name
Lumenis® Smart532TM Laser System and accessories
### Indications for Use (Describe)
The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows:
Ophthalmology
Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG) Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG)
Ear, Nose and Throat (ENT) Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic procedures
Dermatology Pigmented lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases Cutaneous lesions Flat warts Dermatosis Papulosa Nigra
Dentistry Frenectomy Treatment of oral mucous cyst Treatment of benign vascular lesions: Capillary hemangioma Hemorrhagic hereditary telangiectasia Capillary/cavernous hemangiomas Lymphangioma AV malformation of the tongue Hermaniolymphangiomas Photocoagulation of superficial vessels
{3}------------------------------------------------
Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy: Operative procedures Crown and bridge, gingival reduction Crown lengthening Hyperplasia (Drug, irritation, Epulus, ... ) Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct): Hemostasis of donor site Hemostasis of graft site Vestibuloplasty Soften Gutta Percha Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening
Device energy delivery options:
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
# Lumenis Smart532™ Laser System 510(K) Summary
### I. Submitter General Information:
| Device Owner Name: | Lumenis, Inc. |
|-------------------------|-----------------------------------------------------------------------------------------------------------|
| Address: | 1870 S Milestone Dr<br>Salt Lake City, UT 84104 |
| Contact: | Jace R. McLane |
| Phone: | 801-656-2328 |
| Fax: | 801-656-2415 |
| Date of Preparation: | 18 September, 2015 |
| Device Name: | |
| Trade Name: | Lumenis® Smart532™ Laser System |
| Common/Usual Name(s): | Surgical Laser |
| Class: | Class II |
| Classification Name(s): | 79 GEX, Laser Instrument, Surgical Powered |
| CFR Reference: | 21 CFR § 878.4810, Laser surgical instrument for use in<br>general and plastic surgery and in dermatology |
#### III. Predicate Device Name(s):
| Trade Name(s): | Lumenis® Novus Spectra™ Laser System (K022327)<br>Iridex® IQ 532 Laser System (K071687) |
|----------------|-----------------------------------------------------------------------------------------|
|----------------|-----------------------------------------------------------------------------------------|
#### IV. Device Description:
II.
The subject Lumenis® Smart532™ Laser System product is a dual port, solid state, frequency doubled, green Nd:GdVO4 surgical laser instrument used in the photothermolysis (photocoagulation) of soft tissue at an operating emission wavelength of 532nm, a wavelength that has been used widely and effectively in the market for procedures in the fields of ophthalmology, ENT (ear, nose & throat), dermatology and dentistry.
Compatible delivery devices & accessories for use with the subject Lumenis® Smart532™ Laser System include: Slit lamps, Slit lamp adapters/attachments, Laser Indirect Ophthalmoscopes (LIO), Eye safety filters, Laser links, Array LaserLink, Selecta Trio, Fibers and Endo-ocular and Endo-Oto probes. The device software may be adjusted by Lumenis to fit customer needs within the system overall range of parameters.
#### V. Intended Use:
The subject Lumenis® Smart532™ Laser System delivery device is indicated for a variety of uses, identical to unaltered indications from the primary predicate Lumenis® Novus Spectra™ Laser System (K022327), to direct indications enumerated within the product Operator Manual, as follows:
The Lumenis Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows:
Image /page/4/Picture/13 description: The image shows the logo for Lumenis, a medical device company. The logo consists of a stylized letter "L" in blue, followed by the company name "LUMENIS" in a matching blue font. The logo is simple and modern, and the blue color gives it a professional and trustworthy look. The registered trademark symbol is present to the right of the company name.
{5}------------------------------------------------
## Ophthalmology
Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO). Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG)
Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG)
## Ear, Nose and Throat (ENT)
Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic procedures
### Dermatology
Pigmented lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases Cutaneous lesions Flat warts Dermatosis Papulosa Nigra
## Dentistry
Frenectomy Treatment of oral mucous cyst Treatment of benign vascular lesions
- Capillary hemangioma
- Hemorrhagic hereditary telangiectasia ●
- Capillary/cavernous hemangiomas ●
- Lymphangioma
- AV malformation of the tongue ●
- Hemangiolymphangiomas .
Photocoagulation of superficial vessels Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy
- Operative procedures
- Crown and bridge, gingival reduction ●
- . Crown lengthening
Hyperplasia (Drug, irritation, Epulus ... )
Image /page/5/Picture/22 description: The image shows the word "LUMENIS" in blue font. The "L" in LUMENIS is stylized with a blue circle and a vertical line. The word "LUMENIS" is written in all capital letters. There is a registered trademark symbol next to the word "LUMENIS".
{6}------------------------------------------------
Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct):
- Hemostasis of donor site
- Hemostasis of graft site
Vestibuloplasty
Soften Gutta Percha
Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening
### Device energy delivery options
| Energy Delivery Option | Indication |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SmartPulse | Diabetic Retinopathy including Macular<br>Edema or Proliferative Retinopathy,<br>Proliferative Diabetic Retinopathy<br>(PDR), Central Serous Chorioretinopathy<br>(CSCR), Macular Edema or Proliferative<br>Retinopathy associated with Branch<br>Retinal Vein Occlusion (BRVO) |
| CW (Continuous Wave) | All Indications |
#### VI. Substantial Equivalence Discussion:
The subject Lumenis® Smart532™ and primary predicate Lumenis® Novus Spectra™ Laser System (K022327) are based on a diode pumped solid state frequency doubled laser.
Both subject and predicate(s) devices' laser systems (Lumenis® Novus Spectra Laser System (K022327) and Iridex® IQ 532 Laser System (K071687)) share the same 532 nm output, a wavelength that has been used widely and effectively in the market for procedures in the fields of ophthalmology, ENT (ear, nose & throat), dermatology and dentistry. The Iridex IQ 532 Laser System (K071687) is not cleared for any dentistry indications. The outputs of both systems' laser sources also share the same power range characteristics.
Additional design changes such as dual port, addition of touch screen etc., did not raise new questions of safety and effectiveness and did not alter the basic fundamental scientific technology of the device.
The subject device, Lumenis® Smart532 Laser System and primary predicate Lumenis® Novus Spectra Laser System (K022327) do not share the SmartPulse (train of brief pulses) energy delivery method. However, the Iridex® IQ 532 Laser System secondary predicate (K071687) does include a MicroPulse (spaced, single and repetitive train of brief pulses) energy delivery method, which is similar in terms of temporal ranges to the SmartPulse of the subject device and establishes substantial equivalence as shown in the table below:
Image /page/6/Picture/15 description: The image shows the word "LUMENIS" in a sans-serif font. The word is in blue, and the "L" is stylized with a curved shape. The word "LUMENIS" is followed by the registered trademark symbol.
{7}------------------------------------------------
| Characteristics | Subject Device -<br>Lumenis® Smart532™<br>Laser System | Primary Predicate<br>Device - Lumenis®<br>Novus Spectra™ Laser<br>System (K022327) | Secondary Predicate<br>Device – Iridex® IQ<br>532 Laser System<br>(K071687) |
|---------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Indications for<br>Use | Ophthalmic, ENT,<br>Dermatology, &<br>Dentistry | Ophthalmic, ENT,<br>Dermatology, &<br>Dentistry (See<br>K022327) | Dermatology,<br>ENT/otolaryngology, &<br>Ophthalmic (See<br>K071687) |
| Treatment<br>wavelength | 532nm | 532nm | 532nm |
| Aiming beam | Diode, 635nm | Diode, 635nm | Diode, 635nm |
| Laser Type | Diode Pumped Solid<br>State (frequency<br>doubled) | Diode Pumped Solid<br>State (frequency<br>doubled) | Diode, Diode-pumped,<br>frequency doubled,<br>solid state |
| Power Input | 100-240 VAC | 100-240 VAC | 100-240 VAC |
| Power Output | 50-2,500mW (nominal) | 50-1,500mW | 0-2,500mW |
| Operating mode | Single Pulse, CW<br>(Continuous Wave),<br>SmartPulse | Single Pulse, CW<br>(Continuous Wave) | CW(CW-Pulse,<br>MicroPulse, Long<br>Pulse |
| Pulse duration | Single Pulse CW: 5 -<br>3,000msec<br>SmartPulse: 0.05-<br>1.00msec | Single Pulse, CW: 10-<br>3,000msec | CW: 10-3,000msec<br>MicroPulse: 0.05-<br>1.00msec |
| Pulse/Exposure<br>interval | CW: 10-1,500msec<br>SmartPulse: 0.5-10msec | CW: 50-1,000msec | CW: 10-3,000msec<br>MicroPulse: 1.00 -<br>10.00msec |
| Display Type<br>and User<br>Interface | Color display panel<br>w/Touchscreen &<br>pushbutton selectors | Monochromatic seven<br>segment indicators and<br>pushbutton selectors | Color Graphic<br>Touchscreen<br>manual/Remote<br>Controls |
Table 1: 510(k) Summary Device Comparison Table
#### VII. Performance Data:
Appropriate testing for the subject Smart532™ Laser System device, including safety, performance and functional testing, has been performed to determine substantial equivalence to the predicate devices Lumenis® Novus Spectra™ Laser System and Iridex® IQ 532 Laser System .
The subject Lumenis® Smart532™ Laser System product has been subjected to outside independent laboratory testing regarding electrical safety & EMC requirements per governing
Image /page/7/Picture/7 description: The image shows the logo for Lumenis, a medical device company. The logo consists of a stylized letter "L" in blue, followed by the company name "LUMENIS" in blue sans-serif font. A small registration mark is present to the right of the name.
{8}------------------------------------------------
IEC 60601 3"-Edition Series, and side-by-side comparative performance assessment to the identified primary predicate Lumenis® Novus Spectra™ Laser System (K022327). The subject product has undergone verification & validation protocol controlled examination testing to ensure the subject product met all determined design specifications and was determined as substantially equivalent. As a result. Lumenis maintains that all established testing criteria and product performance specifications have been met, demonstrating that equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, patient population, and general modes of operation of the subject device are indeed substantially equivalent to cited predicate devices.
Based on the indications for use, technological characteristics, safety and performance testing, the subject Lumenis® Smart532™ Laser System product meets the requirements considered adequate for its intended use and is substantially equivalent in design, materials, technical features, treatment population, principles of operation and indications for use to current commercially available cited predicates.
#### VIII. Conclusion:
The Lumenis® Smart532™ Laser System subject device has equivalent intended use, general design, and fundamental scientific technology as the predicate devices: Lumenis® Novus Spectra™ Laser System (K022327) and the Iridex® IQ 532 Laser System (K071687). There are no new hazards introduced by the Lumenis® Smart532™ Laser System subject device as compared with the cited predicate devices.
Image /page/8/Picture/6 description: The image shows the logo for Lumenis. The logo is blue and features the company name in a sans-serif font. The logo has a stylized "L" on the left side of the word.
