AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS

K081612 · Aesculight, LLC · GEX · Jun 25, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081612
• Device Name: AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS
• Applicant: Aesculight, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the product(s) is to communicate the laser beam of a CO, surgical laser to the target site for the incision, excision, ablation, or photocoagualtion of soft tissue. Representative examples of clinical applications include: Gynecology--excision and vaporization of cervical, vulvar, and perineal condyloma: ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts Dermatology--port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors General Surgery--hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures Laparoscopic Surgery--vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy Otorhinolaryngology--lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete mattixectomy; porokeratoma ablation; Morton's neurome removal; ingrown toenail treatment Orthopedic -- menisectorny, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal

Device Story

Detachable beam delivery system for CO2 surgical lasers; comprises flexible hollow lightpipe (fiber), handpieces, and rigid alumina tips. User selects handpiece/tip combination for specific clinical task. Fiber transmits laser energy to target site for soft tissue incision, excision, ablation, or photocoagulation. Used in clinical settings (e.g., OR, clinic) by physicians. Aesculight fiber uses internally-coated flexible seamless tubing for improved transmission efficiency compared to predicate molybdenum ribbon. Alumina tips provide conical lumen for beam concentration and higher power throughput. Some handpieces include integral/add-on smoke evacuation. Output is laser beam directed at tissue; enables precise tissue removal/vaporization. Benefits include clinical versatility across multiple surgical specialties and improved power handling/transmission efficiency.

Clinical Evidence

Bench testing only. Laboratory testing confirmed that Aesculight tips produce identical spot sizes to predicate tips, possess similar transmission efficiencies, and have power-handling capabilities that equal or exceed predicate devices.

Technological Characteristics

Flexible hollow lightpipe (fiber) with internally-coated seamless tubing; monolithic alumina tips with conical lumen; handpieces with optional smoke evacuation. Optical multi-mode transmission. Sterilization not specified. No software/algorithm.

Indications for Use

Indicated for soft tissue incision, excision, ablation, or photocoagulation in gynecology, dermatology, dentistry/oral surgery, general surgery, laparoscopic surgery, otorhinolaryngology, podiatry, and orthopedic procedures.

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

• Modified LX-20 Laser System fibers, handpieces, and tips (K960475)

Submission Summary (Full Text)

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SURGICAL LASERS

1-866-697-7548 425-483-8905 Fax [phone]

JUN 2 5 2008 KO81612

## 510(k) Summary

SURICAL

Date prepared: June 2, 2008

### Submitter's name, address, telephone, fax, and contact person;

Aesculight LLC 16928 Woodinville-Redmond Rd N.E., Suite B104 Woodinville, WA 98072 [phone] telephone [phone] fax Paul Diaz, Vice President of Engineering

Product trade name: Aesculight family of fibers, handpieces, and tips for CQ surgical lasers

Product common name: Laser flexible fibers, handpieces, and tips

Classification names: General and Plastic Surgery Devices, 21 CFR, 878.4810, product code GEX; ENT Microsurgical CO2 Laser, 21 CFR874.4500, product code EWG; Gynecologic Surgical Laser, 21 CFR 884.4550, product code HHR; Soft Tissue Dental Laser, 21 CFR 878.4810, product code NVK

Legally marketed predicate device: Modified LX-20 Laser System fibers, handpieces, and tips, as described in 510(k) no. K960475

## Product description

This is a family of detachable devices that comprise the distal portion of a beam delivery system to be used with a CO, surgical laser such as that described in K96075. Specifically, the devices consist of a flexible hollow lightpipe (fiber), handpieces that connect to the fiber, and various tips that connect to the handpieces. The tips are short, rigid hollow alumina lightpipes producing a variety of spot sizes. The user may "mix and match" handpieces and tips to suit the clinical task at hand.

### Intended vse

The intended use of the product(s) is to communicate the laser beam of a CO, surgical laser to the target site for the incision, excision, ablation, or photocoagualtion of soft tissue. Representative examples of clinical applications include:

Gynecology--excision and vaporization of cervical, vulvar, and perineal condyloma: ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts

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Dermatology--port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis

Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors

General Surgery--hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures

Laparoscopic Surgery--vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy

Otorhinolaryngology--lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps

Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete mattixectomy; porokeratoma ablation; Morton's neurome removal; ingrown toenail treatment

Orthopedic -- menisectorny, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal

No new indications for use are sought beyond those associated with the predicate devices.

#### Technological characterization

When used with a CO, laser, the effect on tissue of the laser beam, as produced by the Aesculight family of products, is identical to that of the predicate products. The Aesculight tips produce the same range of spot sizes as the predicate tips. Cosmetically, dimensionally, and ergonomically, the Aesculight products are very similar to the predicates, and use the same optical principles to conduct the laser light from the base unit to the target site. There are, in some cases however, some differences in construction. The predicate fiber is based upon an optically-coated (for enhanced reflectivity) molybdenum ribbon formed into a long skinny tube (with the optical coating on the inside surface), whereas the Aesculight fiber is based upon internally-coated flexible seamless tubing, This tubing, with no seams or gaps in the optical coating, exhibits somewhat better transmission efficiency than the predicate fiber. While some of the Aesculight tips are identical in construction to the predicate tips, some are not. To produce the smaller spot sizes, the predicate tips use a cone of coated molybdenum ribbon to concentrate the beam, whereas the Aesculight tips are monolithic alumina with a conical lumen. The alumina tips are capable of sustaining higher power throughputs than the predicate foil tips. These differences in construction do not introduce any new safety or performance concerns.

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The Aesculight handpieces, for the most part, exhibit only minor cosmetic differences to the predicate handpieces. In one case (the backstop handpiece), the Aesculight handpiece is a shorter version of the predicate, and in other cases, Aesculight produces more handpiece models with integral or add-on smoke evacuation capabilities, but these differences merely affect the convenience of use of the handpieces, and have no effect on the laser beam-tissue interaction.

#### Conclusion

The Aesculight fiber, although differing somewhat in construction, has very similar physical and optical characteristics as the predicate fiber. Both are flexible, optically multi-mode, hollow lightpipes, and both have the same lumen size and length, with the Aesculight version exhibiting superior transmission efficiency. In some cases, the Aesculight handpieces are almost identical to the predicate handpieces; in other cases, the Aesculight handpieces are simple mechanical modifications of the predicate handpieces with the object of providing more convenience for the user. The Aesculight tips are, in some cases, exactly identical to the predicate tips; in other cases, the construction (but not the internal geometry) differs from the predicates, and laboratory bench testing confirms that the spot sizes produced by the Aesculight tips are identical to the predicate tips, that the Aesculight tips have similar transmission efficiencies as the predicate tips and have power-handling capabilities that equal or exceed those of the predicate tips. From a clinical efficacy standpoint, a user could not distinguish a difference between the predicate products and the Aesculight products, nor do the Aesculight products raise any new safety issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 5 2008

Aesculight, LLC % Mr. Paul Diaz Vice President of Engineering 16928 Woodinville-Redmond Road Northeast, Suite B104 Woodinville, Washington 98072

K081612 Re:

Trade/Device Name: The Aesculight family of flexible fibers, handpieces,

and tips for CO2 surgical lasers

Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II Product Code: GEX Dated: June 5, 2008 Received: June 9, 2008

Dear Mr. Diaz:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Paul Diaz

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Device name: The Aesculight family of flexible fibers, handpieces, and tips for CO, surgical lasers

#### Indications for use: Representative examples are listed below.

Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.

Dermatology--port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis

Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors

General Surgery--hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures

Laparoscopic Surgery-vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy

Qtorhinolaryngology--lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps

Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete matrixectorny; porokeratoma ablation; Morton's neurome removal; ingrown toenail treatment

Orthopedic-menisectomy, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal

| Prescription Use | Yes | AND/OR | Over-The-Counter Use | No |
|-----------------------------|-----|--------|------------------------|----|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |

Concurrence of CDRH, Office of Division Sign-Off (ODE)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | 11081612 |
|---------------|----------|
|---------------|----------|