Who is the manufacturer of PINPOINTE FOOTLASER?

Pinpointe USA, Inc. filed the 510(k) submission for PINPOINTE FOOTLASER (K093547).

What is the FDA product code for PINPOINTE FOOTLASER?

PDZ. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PINPOINTE FOOTLASER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PINPOINTE FOOTLASER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PINPOINTE FOOTLASER

K093547 · Pinpointe USA, Inc. · PDZ · Oct 15, 2010 · General, Plastic Surgery

Device Facts

Record ID	K093547
Device Name	PINPOINTE FOOTLASER
Applicant	Pinpointe USA, Inc.
Product Code	PDZ · General, Plastic Surgery
Decision Date	Oct 15, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillofacial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery. The PinPointe™ FootLaser™ 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.).

Device Story

PinPointe FootLaser is a flashlamp-pumped solid-state Nd:YAG laser system (1064 nm) used for soft tissue surgery and onychomycosis treatment. System includes main console with control panel, footswitch, aiming beam (630-680 nm), and various delivery devices (fiber-optic handpieces, guide tips). Physician operates system via footswitch to deliver pulsed laser energy to target tissue or nail. Aiming beam assists in positioning. Device enables precise tissue ablation, vaporization, and coagulation. In onychomycosis, laser energy targets nail bed/plate to promote clear nail growth. Used in clinical settings (dermatology, podiatry, surgery). Output allows clinicians to perform minimally invasive procedures or treat nail fungal infections, potentially improving patient nail appearance and clinical outcomes.

Clinical Evidence

Clinical study demonstrated safety and effectiveness for temporary increase of clear nail in patients with onychomycosis (dermatophytes/yeasts) at 6 and 12 months post-treatment.

Technological Characteristics

Flashlamp-pumped solid-state Nd:YAG laser; 1064 nm wavelength; 630-680 nm aiming beam; pulsed output mode (5-100 Hz); 20-200 mJ pulse energy; ≤ 6W power; 100-700 μsec pulse duration. System includes console, footswitch, and reusable/sterilizable fiber-optic delivery devices. Electrical requirements: 90-130 VAC or 200-240 VAC, 50/60 Hz. Dimensions: 32" x 13" x 14"; Weight: 17.2 kg.

Indications for Use

Indicated for patients with onychomycosis (dermatophytes/yeasts) for temporary increase of clear nail; also indicated for soft tissue surgical procedures (ablation, vaporization, excision, incision, coagulation) in dentistry, ENT, dermatology, plastic surgery, and general surgery.

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

PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers (K083616)
Incisive Family of InPulse Nd:YAG Lasers (K083215)

Related Devices

K130413 — PINPOINTE FOOTLASER · Nuvolase, Inc. · Mar 21, 2013
K093545 — PINPOINTE FOOTLASER MODEL 6W, 30W, 100W · Incisive, Inc. (Formerly Named Incisive, LLC) · Oct 15, 2010
K113702 — FOTONA XP ND: YAG LASER SYSTEM · Fotona D.D. · Mar 28, 2012
K110370 — Q-CLEAR · Light Age, Inc. · Sep 15, 2011
K111483 — JOULE CLEARSENSE LASER SYSTEM · Sciton, Inc · Dec 7, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ 693547 CONFIDENTIAL Section 5 - 510(k) Summary DCT1 5 2010 ### I. General Information Submitter: PinPointe USA. Inc. 275 Airpark Boulevard Suite 100 Chico, CA 95973 530-809-3800 Tel: Fax: 866-235-1386 USA. Inc. John Strisower Chief Executive Officer, PinPointe USA, Inc Summary Preparation Date: October 13, 2010 II. Names Trade Name(s): Contact Person: PinPointe™ FootLaser™ (and delivery device accessories) Common Name(s): Laser Powered Surgical Instruments Primary Classification Names: Laser Powered Surgical Instruments (and Accessories) (21 CFR Part 878.4810, Product Code GEX) ### III. Predicate Devices - PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers ● (K083616) - Incisive Family of InPulse Nd: Y AG Lasers (K083215). . ### Product Description IV. : . The PinPointe™ FootLaser™ is comprised of the following main components: - Main console containing the major electrical components, including: - > Control/ Display Panel with the: - Kevswitch (that controls authorized access to the laser system); ● - emergency Laser Stop button; . - Displays (laser emission indicator, average power, pulse energy, . repetition rate) - Standby button (default mode when laser system turned on places . system into the Standby mode preventing laser emission). - Ready button (places system into the Ready mode allowing laser ● cmission when the footswitch is depressed and a fiber optic is properly attached); - 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and > associated light regulation components and electronics; - A 630 -680 nm (red) aiming beam diode laser; - Delivery device fiber-optic connector port; A - Remote interlock connector (External door interlock connector); A {1}------------------------------------------------ K093547 - Connector ports for the footswitch and power cord; A - Accessory holder (attached to the rear of the main console); A - . Footswitch; A - Medical grade power cord; . - Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue: . - No Standoff: Reusable, cleanable, tip is provided for non-Guide Tip contact use to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip; - > Guide Tip -With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment The Guide tip attaches to the end of the location. The optical fiber is threaded through the handpiece. handpiece and fits securely into the bore of the Guide tip; - Delivery Devices for Contact with Breached Surfaces: ● - Reusable, cleanable, sterilizable optical fibers (range of A Optical Fibers . 200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave). - Handpieces -Reusable, cleanable, sterilizable handpieces (large and A small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap; - Handpiece Tips Disposable single-use tips are provided in straight and A curved configurations and are used to direct and control the placement of the optical fiber tip at the treatment The handpiece tips attach to the end of the location. handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip; - . Accessories: - A Safety Glasses - . Tools: - Optical Fiber Striper; A - Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving A the optical fibers). #### V. Indications for Use The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillofacial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery. {2}------------------------------------------------ ### Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - . Radical nail excision - . Periungual and subungual warts - Plantar warts . - . Neuromas Plantar warts Removal of tattoos Treatment of keloids The PinPointe™ FootLaser™ 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.). D . . . . ### Dermatology and Plastic Surgery Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Lesions of skin and subcutaneous . ● tissue . - . Telangiectasia : - Port wine lesions . - Spider veins . - Hemangiomas ● ## Oropharangeal / Dental Surgery Indicated for: - Abscess incision and drainage . - Aphthous ulcers treatment . - . Biopsies, excisional and incisional - Crown lengthening ● - Exposure of unerupted / partially . erupted teeth - . Fibroma removal - Frenectomy . - Frenotomy ● - Gingival incision and excision ● - Gingivectomy .� - . Gingivoplasty - Hemostasis ● - Implant recovery . - Lesion (tumor) removal . - . Leukoplakia - Operculectomy ● - Oral papillectomy . ## General Surgery Indicated for: . - - Pulpotomy ● Pulpotomy as adjunct to root canal � therapy Periungual and subungual warts Debridement of decubitus ulcer - . Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment - . Selective ablation of enamel (first degree) caries removal - Sulcular debridement (removal of . diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index. probe depth, attachment loss, and tooth mobility - Tissue retraction for impressions . - Vestibuloplasty � - Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, . incision, excision, and coagulation of soft tissue) including: - 1 . - Cholecystectomy . - Lymphadenectomy - - Mastectomy - - Partial nephrectomy - Hepatectomy . - -Parathyroidectomy -Removal of tumors Removal of lesions Removal of polyps Thyroidectomy Premarket Notification, 510(k) Submission for: PinPointe™ FootLaser™ {3}------------------------------------------------ # Kog3547 ### CONFIDENTIAL - Pilonidal cystectomy . - Pancreatectomy - - Resection of lipoma - - -Splenectomy - Pelvic adhesiolysis - - Hemorrhoidectomy ↓ - Herniorrhaphy . - Tumor biopsy . - Tonsillectomy . - Debridement of decubitus ulcers . - Appendectomy . ### Endonasal Surgery Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including: - � Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues - Tonsillectomy . - Adenoidectomy . The safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail in patients with onychomycosis was demonstrated in clinical studies. ### VI. Summary of Technological Characteristics The technological characteristics of the PinPointe™ FootLaser™ are identical to those of the predicate devices. | Characteristic | K093545 - PinPointe™ FootLaser™ and Delivery Devices; Incisive, Inc. | | | K083616 - PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Lasers; PathoLase, Inc. | | | K0832153 - Incisive Family of InPulse Nd:YAG Lasers; Incisive, LLC | | | |------------------------------------|----------------------------------------------------------------------------|------------|------------|--------------------------------------------------------------------------------------------------|------------|-----------|--------------------------------------------------------------------------|------------|------------| | Wavelength | 1064 nm | | | 1064 nm | | | 1064 nm | | | | Aiming Beam | 630-680 nm (≤ 2.5 mW) | | | 630-680 nm (≤ 2.5 mW) | | | 630-680 nm (≤ 2.5 mW) | | | | Model | 6 W | 30 W | 100.W | 6 W | 30 W | 100 W | 6 W | 30 W | 100 W | | Energy Per Pulse (mJ) | 20-200 | 20-1000 | 20 - 3500 | 20-200 | 20-1000 | 20 - 3500 | 20-200 | 20-1000 | 20 - 3500 | | Power (Watts) | ≤ 6 | ≤ 30 | ≤ 100 | ≤ 6 | ≤ 30 | ≤ 100 | ≤ 6 | ≤ 30 | ≤ 100 | | Pulse Duration (μsec) | 100 - 700 | 350 - 3000 | 350 - 3000 | | 100 - 3000 | | 100 - 700 | 350 - 3000 | 350 - 3000 | | Output Mode | Pulsed, Multi-Mode | | | Pulsed, Multi-Mode | | | Pulsed, Multi-Mode | | | | Repetition Rate | 5 - 100 Hz | | | 5 - 100 Hz | | | 5-100 Hz | | | | Laser Media | Flashlamp-Pumped Solid State Laser Rod | | | Flashlamp-Pumped Solid State Laser Rod | | | Flashlamp-Pumped Solid State Laser Rod | | | | User Interface | Push-button control panel | | | LCD Color touch screen | | | Push-button control panel | | | | Laser Activation | Footswitch | | | Footswitch | | | Footswitch | | | | Delivery Devices • How supplied | • Non-sterile, reusable, cleanable, sterilizable | | | • Non-sterile, reusable, cleanable, sterilizable | | | • Non-sterile, reusable, cleanable, sterilizable | | | | System Dimensions | 32" x 13" x 14" (H x W x D) | | | 32" x 13" x 14" (H x W x D) | | | 32" x 13" x 14" (H x W x D) | | | | System Weight | 17.2 kg (38 lbs) | | | 17.2 kg (38 lbs) | | | 17.2 kg (38 lbs) | | | | Electrical Reqs. | 90-130 VAC, 50/60 Hz 200-240 VAC, 50/60 Hz | | | 90-130 VAC, 50/60 Hz 200-240 VAC, 50/60 Hz | | | 90-130 VAC, 50/60 Hz 200-240 VAC, 50/60 Hz | | | {4}------------------------------------------------ Clinical study demonstrated the safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). ### VIII. Safety and Effectiveness Information The review of the indications for use, technical characteristics, and clinical study results provided demonstrates that the PinPointe™ FootLaser™ is substantially equivalent to the predicate devices and is safe and effective for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis. ### IX. Conclusion The PinPointe™ FootLaser™ was found to be substantially equivalent to the predicate devices. The PinPointe™ FootLaser™ share identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings, positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is circular in shape. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 13, 2013 PinPointe USA. Inc. % Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566 Re: K093547 Trade/Device Name: PinPointe FootLaser 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: PDZ, GEX Dated: October 13, 2010 Received: October 14, 2010 Dear Ms. Worden: This letter corrects our substantially equivalent letter of October 15, 2010. 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. Ilsting 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 {6}------------------------------------------------ Page 2 - Ms. Anne Worden 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 (OS) 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/ReportalProblem/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 vours. 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 {7}------------------------------------------------ Indications for Use Statement OCT 1 5 2010 | 510(k) Number (if known): | K093547 | |---------------------------|-----------------------| | Device Name: | PinPointe™ FootLaser™ | | Indications for Use: | | The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialites of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery. ### Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - . Periungual and subungual warts - Plantar warts ● - Radical nail excision ● - Neuromas . The PinPointe™ FootLaser™ 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.). *** Page 1 of 4 *** Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R.P. Ogden for mxm Division Size 500 (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K093547 Page 1 of 4 Premarket Notification, 510(k) Submission for: PinPointe™ FootLaser™ Section 4: Indications for Use {8}------------------------------------------------ ## Indications for Use Statement - Continued 510(k) Number (if known): K093547 | Device Name: | PinPointe™ FootLaser™ | |--------------|-----------------------| |--------------|-----------------------| Indications for Use - Continued: ### Dermatology and Plastic Surgery Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Lesions of skin and subcutaneous tissue . - Telangiectasia . - Port wine lesions ● - . Spider veins - Hemangiomas ● - Plantar warts ● - . Periungual and subungual warts - Removal of tattoos . - Debridement of decubitus ulcer ● - . Treatment of keloids ## Oropharangeal / Dental Surgery Indicated for: - Abscess incision and drainage . - Aphthous ulcers treatment . - Biopsies, excisional and incisional . - Crown lengthening ● - Exposure of unerupted / partially erupted teeth - . Fibroma removal - . Frenectomy - Frenotomy . - Gingival incision and excision ● > - Gingivectomy ● - . Gingivoplasty Prescription Use (Part 21 CFR 801 Subpart D) *** Page 2 of 4 *** Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number: K093547 **Page 2 of 4** Premarket Notification, 510(k) Submission for: PinPointe™ FootLaserTM Section 4: Indications for Use {9}------------------------------------------------ ## Indications for Use Statement - Continued 510(k) Number (if known): K093547 Device Name: PinPointe™ FootLaser™ Indications for Use - Continued: ### Oropharangeal / Dental Surgery - Continued Indicated for: - Hemostasis . - Implant recovery - . Lesion (tumor) removal - Leukoplakia . - . Operculectomy - Oral papillectomy ● - Pulpotomy ● - Pulpotomy as adjunct to root canal therapy . - Removal of filling material such as gutta percha or resin as adjunct treatment during root . canal re-treatment - . Selective ablation of cnamel (first degree) caries removal - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal ● pocket) to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility - Tissue retraction for impressions - Vestibuloplasty ● ## General Surgery Indicated for: - Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, . excision, and coagulation of soft tissue) including: - Cholecystectomy - - Lymphadenectomy . - Mastectomy . - Partial nephrectomy . - Hepatectomy . Prescription Use > (Part 21 CFR 801 Subpart D) *** Page 3 of 4 *** AND/OR Over-The-Counter Use . (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) \$\frac{\text{Nid R.P.Q.den}}{\text{(Division Sigh-Off)}}\$ for MXM Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K093547 **Page 3 of 4** Premarket Notification, 510(k) Submission for: PinPointe™ FootLaser™ Section 4: Indications for Use {10}------------------------------------------------ ### Indications for Use Statement - Continued 510(k) Number (if known): K093547 ## Device Name: PinPointe™ FootLaser™ ### Indications for Use - Continued: ## General Surgery - Continued Indicated for: - Pilonidal cystectomy - - Pancreatectomy . - Resection of lipoma . - Splenectomy - - Pelvic adhesiolysis - - Hemorrhoidectomy - - Removal of lesions - - Thyroidectomy - - Removal of polyps - - Parathyroidectomy - - Removal of tumors - - Hemiorrhaphy . - Tumor biopsy . - Tonsillectomy . - Debridement of decubitus ulcers . - Appendectomy ### Endonasal Surgery Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues ● - . Tonsillectomy - Adenoidectomy . *** Page 4 of 4 *** | Prescription Use (Part 21 CFR 801 Subpart D) | ✓ | |-------------------------------------------------|---| |-------------------------------------------------|---| AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | | |------------------------------------------------|--| |------------------------------------------------|--| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ### Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R.P. Ogden for mam (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K093547 **Page 4 of 4** Premarket Notification, 510(k) Submission for: PinPointe™ FootLaser™ Section 4: Indications for Use