(54 days)
Not Found
No
The summary describes a multi-platform laser/light system for various surgical and aesthetic applications. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The description focuses on the physical components and the intended uses of the different wavelengths of light.
Yes
The device clearly states its intended uses for various medical specialties, including surgical and aesthetic applications for treating a wide range of conditions, such as vascular lesions, pigmented lesions, hair removal, wrinkles, soft tissue incision/excision, and several dermatological, gastrointestinal, gynecological, and orthopedic conditions. These applications are aimed at treating diseases, injuries, or conditions, which falls under the definition of a therapeutic device.
No
This device is a multi-wavelength laser/light system intended for various surgical and aesthetic applications, including incision, excision, ablation, vaporization, coagulation, and hemostasis of soft tissue, as well as dermatological treatments and hair removal. Its stated uses are for treatment and alteration of tissues, not for diagnosing conditions.
No
The device description explicitly states it is a "modular, multi-wavelength laser/light system" consisting of a "control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner." This indicates significant hardware components beyond just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device's Intended Use: The intended uses described for the Profile Multi-Platform Systems and Accessories are all related to surgical and aesthetic applications performed directly on the patient's body. This includes procedures like cutting, ablation, coagulation, hair removal, skin resurfacing, and treatment of various lesions and conditions.
- Lack of Mention of Samples: The text does not mention the device being used to analyze samples taken from the body. The procedures described involve direct interaction with the patient's tissues.
Therefore, the device falls under the category of a medical device used for treatment and surgical procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
1064 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.
The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
1320 nm Indications for Use;
The Profile Multi-Platform Systems and Accessories are intended for use in general surgery and dematology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.
Profile 2000 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications:
Dermatology and Plastic Surgery
Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization.
Gastroenterological/Gastrointestinal Surgery
Open and endoscopic gastroenterologic surgery of soft tissue(for incision, excision, resection, ablation, vaporization, coagulation and hernostasis) including;
cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotorny, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, uicers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding furnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Oster-Weber-Rendu disease.
General Surgery
General surgery of soft tissues, including; skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectorny, hepatectorny, pancreatectorny, splenectorny, thyroidectorny, parathyroidectorny, herniorthaphy, tonsillectorny, lymphadenectorny, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectorny, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectomy.
Genitourinary Surgery/Urology
Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, ablation of benign prostatic hypertrophy, transurethral incision of prostate, laser resection of the prostate, laser enuculeation of the prostate, laser ablation of the prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynecological Surgery
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, including condyloma acuminate, intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septurn by incision, excision, ablation and or vessel coagulation, soft tissue excision procedures such as excisional conization of the cervix.
Lithotripsy and Percutaneous Urinary Lithotripsy
Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.
Lumbar Discectorny
Lumbar discectorny in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy.
Orthopedic Surgery and Arthroscopy
Orthopedic surgery in soft and catiliaginous tissue in small and large joints, including. knee meniscectorny, knee synovectorny, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectorny in the knee, chondroplasty in the knee, chondromalacia ablation, ablation of soft and cartilaginous tissue in minimal invasive spinal surgery including percutaneous laser disc decompression/ discectorny, foraminoplasty, ablation and coaqulation of soft vascular and non-vascular tissue in minimally invasive spinal surgery.
Otorhinolaryrigological (ENT) Surgery
Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue. including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectorny), dacı yocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty, lesions or turnors of the oral, nasal, glossal, pharyngeal, tonsillectomy, adenoidectorny, adenoidectorny.
Thoracic and Pulmonary Surgery
Open and endoscopic thoracic and pulmonary surgery (incision, resection, ablation. vaporization, coagulation and hernostasis) of soft tissue, including laryngeal lesions, airway obstructions including carcinoma, polyps and granulomas, palliation of obstructing carcinomas of the tracheobroncial tree.
2940 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dental Application of Er: YAG
It is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.
Hard Tissue Indications of Er. YAG Laser Energy: Caries removal, cavity preparation, enamel etching, enameloplasty, excavation of pits and fissures for placement of sealant.
Bone Indications of Er YAG Laser Energy: Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue, apicoectorny, osseous crown lengthening, culting bone to prepare a window access to the apex of the root, osseoplasty, osteotomy.
Soft Tissue and Periodontal Indications of Er.YAG Laser Energy. Excisional and incisional biopsies, exposure of unerrupted teeth, incision and drainage of abscesses, gingival incision and excision, gingivoplasties, gingivectomies, gingivectorny in case gingwal mondow of the gingival or excision of hyperplasias, gingival troughing for or nyperplasias of the girls of the start recovery, frenectomies and frenotomies, fibromatosis, benign and malignant lesion removal, operculectorny, oral papillectornies, reduction of gingival hypertrophy, soft tissue crown lengthening, papilletin surgery (flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibrormatoses, benign growths), vestibuloplasty, sucular debridement.
Endodontal Applications of Er.YAG Laser Energy: Tooth preparation to obtain access to root canal, pulpotomy, pulpotomy as an adjunct to root canal therapy, pulp extirpation, root canal debridement and cleaning, root canal preparation including enlargement.
Dermatology & Plastic Surgery
Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation.
Gastroenterology
Gastroenterologic surgery of soft tissue, including: cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, nonbleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding turnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery
The Er: YAG is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation.
Genitourinary/Urology
Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder turnors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynocology
Indications include cervical intracpithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology
Optimalitions include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Oral/Maxillofacial
Indications include oral/dental procedures for incision, excision, ablation, vaporization mulations more of soft tissue during gingivoplasties, gingivectornies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotorny.
Otorhinolaryrigological (ENT) Surgery
Otominolaryngological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate including. Chaosinus ourgery, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty.
Podiatry
Indications include warts, plantar verruae, large mosaic verrucae and matrixectorny.
Pulmonary Surgery
Open and endoscopic pulmonary surgery.
Thoracic Surgery
Intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.
Pulsed Light (300-1400 nm) Indications for Use:
I he Profile Multi-Platform Systems and Accessories are indicated for use in surgical, assthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for
- The treatment of tattoos; (560nm LP filter, 590nm LP filter)
- The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP fifter, 560nm I_P filter)
- The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter)
- The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erytherna of rosacea, angiomas and spider angiomas, poikilodema of Civatte, leg veins and venous malformations; (580nm LP filter, 590nm LP filter)
- Treatment of psociasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis: (350nm BP filter)
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
- (590nm LP filter, 640nm LP filter, 695 LP filter)
- Mild to moderate inflammatory and pustular inflammatory acne vulgaris, (420nm BP filter, 515nm LP filter, 560 LP filter)
The integral thermo-electric cooler is indicated for use in cooling the epidemis at the r the integral them of during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
- Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
- Reduce discomfort during and/or associated with light or laser treatment:
- Ninimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
- Allow the use of higher light or laser fluences for light or laser treatments (such Allow the use of mgner light of the treatment of vascular or pigmented lesions); and
- as for hair removal and the a suarront of laser treatments (such as for hair removals and the treatment of vascular or pigmented lesions).
Product codes
GEX
Device Description
The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023881, K041879, K032459, K051434, K043046, K042000, K050738, K040005, K051167, K040005, K040270, K032460, K051268
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 060033
. . .
Attachment IV
510(k) Summary
| Submitter: | Sciton, Inc. |
|---|---|
| Address: | 925 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax : | (650) 493-9146 |
| Contact Person: | Jay M. Patel, VP of Regulatory Affairs |
| Date Prepared: | January 4, 2006 |
| Device Trade Name: | Profile Multi-Platform System |
| Common Name: | Laser/Light Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed | |
| Predicate Device: | K023881: Profile 1064 Laser System and Accessories |
| K041879: Palomar Lux 1064 Nd:YAG Handpiece | |
| K032459: Profile 1320 Laser System | |
| K051434: CoolTouch NS-160 Nd:YAG Laser System | |
| K043046 - CoolTouch CT3S Nd:YAG Laser System | |
| K042000; Lovely II and Lovely III | |
| K050738: FT Fiber Optic Delivery Systems | |
| K040005: Profile 2000 and Profile 3000 Laser Systems | |
| K051167: Revolix and RevoLix Jr. | |
| K040005: Profile 2000 and Profile 3000 Laser Systems | |
| K040270: OpusDent Family Dental Laser | |
| K032460: Profile BBL System | |
| K051268: Radiancy Acne System | |
| Description of | |
| Profile Multi-Platform | |
| System | The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. |
| The system uses scanning and focusing optics to deliver a pattern of thermal | |
| energy to the treatment site. The system consists of control console which houses the | |
| power supply, cooling system, fiber optic delivery system and/or articulated arm | |
| delivery system with handpiece and/or scanner. | |
| intended Use: | 1064 nm Indications for Use: |
| The Profile Multi-Platform Systems and Accessories are intended for use in the | |
| medical specialties of general and plastic surgery, dermatology, | |
| endoscopic/laparoscopic general surgery, gastroenterology, gynecology, | |
| otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, | |
| pulmonary/thoracic surgery and urology for surgical and aesthetic applications. | |
| Dermatology: | |
| Coagulation and hemostasis of benign vascular lesions such as, but not limited to | |
| port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins | |
| and spider veins. The lasers are also intended for the treatment of benign pigmented | |
| lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), | |
| café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, | |
| keratoses, tattoos (significant reduction in the intensity of black and/or blue/black | |
| tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to | |
| reduce lesion size, for patients with lesions that would potentially benefit from | |
| aggressive treatment, and for patients with lesions that have not responded to other | |
| aggressive treatments. |
1
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for (Frough Bollettis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.
The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal eboling of the than phot (of alling laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the masterials of surgical applications in endoscopy/laparoscopy/, gastroenterology. general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
1320 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are intended for use in general rne Fromo make incision, excision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
mill to modelate mith fiber delivery is indicated for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.
Profile 2000 nm Indications for Use.
The Profile Multi-Platform Systems and Accessories are indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications:
Dermatology and Plastic Surgery
Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization. Gastroenterological/Gastrointestinal Surgery
Open and endoscopic gastroenterologic surgery of soft tissue(for incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including. cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotorny, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varioes, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal uicer, non-bleeding ulcer, gastric erosions, colorectal cancer. ancetritis, bleeding turnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery
General surgery of soft tissues, including; skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectorny, hepatectorny, pancreatectorny, splenectorny, thyroidectorny, parathyroidectorny, herniorrhaphy, tonsillectorny, lymphadenectomy, partial nephrectorny, pilonidal cystectorny, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectorny, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectorny. Genitourinary
2
Surgery/Urology
Surgery of soft tissue, including: treatment of bladder, ureatment of bladder, ureprinement Gentounnary sugery of Soll usbury invasive bladder turnors; invasive bladder carcinomas; ureteral turnors, supervicial unnaly blodder turns. Invest of the external genitalia, condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, ablation of benign prostatic Enouscopic transurethral incision of prostate, laser resection of the prostate, laser frypertrophy, transdreament of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, the proation and excision for treatment of benign prostatic hypertrophy.
Gynecological Surgery
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, Open and laperosoople gyneoorogios: on your soft tissue, including condyloma vaporization, coagulation and nomos action or submucous fibroids, benign endometrial polyps acuminate, intra-aterine accision, ablation and or vessel coagulation, soft and define beptames such as excisional conization of the cervix.
Lithotripsy and Percutaneous Urinary Lithotripsy
Lithouripsy and I creduneous online ithotripsy, including: fragmentation of urinary Citiou psy and percularieous annaly iknown of increase with in the pregnentation calculi, fragmentation of balouil in the the the the tratment of distal impacted fragments of steinstrasse when guide wires cannot be passed.
Lumbar Discectorny
Lumbal Discectorny in soft, cartilaginous and bony tissue, including: vaporization of Eurnbar Gloostomy 11 5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy.
Orthopedic Surgery and Arthroscopy
Orthopedic surgery in soft and cartilaginous tissue in small and large joints, including Onthopedio aurgery in toe synovectorny, chondrornalacia and tears, loose body Rhee meniscectorry, Rhee Synovoteins, Vica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectorny in the knee, chondroplasty in the knee, choondromalacia ablation, ablation of soft and cartilaginous tissue in minimal invasive chondromalaola abiktion, ablutaneous laser disc decompression/ discectomy, spinal surgery molading porcessary ation of soft vascular and non-vascular tissue in
minimally invasive spinal surgery.
Otorhinolaryrigological (ENT) Surgery
Otominolaryrigological (ENT) surgery in soft, mucosal, cartifaginous and bony tissue, Olominoral yrigerogroum (C. F.) functional endoscopic sinus surgery, turbinate
mcluding, entrolines ourger); furbinectorny), dacryocystorhinostomy (DCR),
procedures (E.g. turbinophony, maxillary antrotomy, frontal sinusotomy,
ethnoldeotomy, polypotently, marmagic telangectasia, septoplasty, lesions of tumors sphenolololority, nereolary nomornogra changeal, tonsillectorny, adenoidectorny, Thoracic and Pulmonary Surgery
Tibrade and I almonary surgery surgery (incision, excision, excision, resection, Open and endoscopic thorado and hemostasis) of soft tissue, including laryngeal ablation, vaponzation, coaguetion and nomotions, or established and granulomas, palliation of obstructing carcinomas of the tracheobroncial tree.
2940 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are designed for use in surgical The Fronte Muni-Flutton, eyelsine acision, ablation, vaporization, and coagulation of applications requiring the exolorial, matth, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. fragments, massual mod applications include general surgery, plastic surgery, Surglical speolance and applications of the cology, genitourinary, ENT, pulmonary aesthelle surgery, podiatry, oral & maxillofacial surgery, opthamology surgery, thoracic surgery, poulutily, oral armanthroscopy, microdiscectomies, and endoscopic procedures.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
3
Dental Application of Er. YAG
It is indicated for a variety of hard tissue (tooth and bone) applications, and for the If is indicated for a variety of hard tissue (tooth this bone) application of soft tissue in oral and maxillofacial surgery and dentistry.
and maxilloracial surgery and uentistry.
Hard Tissue Indications of Er.YAG Laser Energy: Caries removal, cavity placement of rtal Trssue Indications of CF. FAC Court of pits and fissures for placement of sealant.
sealant.
Bone Indications of Er YAG Laser Energy: Contact and non-contact cutting, shaving, Bone mulcations of EF 17 (O EBSEF Energy, or apicoectorny, osseous crown contouning, and resection of erare a window access to the apex of the root, osseoplasty, osteotomy.
Soft Tissue and Periodontal Indications of Er. YAG Laser Energy: Excisional and incisional biopsies, exposure of unerrupted teeth, incision and drainage of abscesses, masonal blopsies, exposure of ancerapiesties, gingivectomies, gingivectorni in case
gingival incision and excision, gingivoplasties, gingivectornies, increasing for gingival mortion and Excision of hyperplasias, gingival troughing for of flyperplasias on the giftyral of explant recovery, frenectomies and frenotomies,
crown impressions, hemostasis, implant recovery, frenectomics and crown impressionia, non malignant lesion removal, operculectorny, oral mornatosis, bettigh of gingival hypertrophy, soft tissue crown lengthening. papillectornes, readouble of girls. Just in the every exposure of implants, preprosurede surgery (nabby and fibrormatoses, benign growths), vestibuloplasty, sucular debridement.
Sucular debhoement.
Endodontal Applications of Er. YAG Laser Energy: Tooth preparation to obtain access Endodonal Appliodiomy, pulpotomy as an adjunct to root canal therapy, pulp extirpation, root canal debridement and cleaning, root canal preparation including enlargement.
Dermatology & Plastic Surgery
Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, marcations marade, ophaermanal tags, keratoses, scar revision, debulking benign kelolus, verrabbe, than tago, and tags, for laser assisted site preparation for hair transplantation.
Gastroenterology
Gastroenterologic surgery of soft tissue, including: cholecystering, iysis of Gastroenterologic surgery of Solt devologic stenotomy, benign and malignant lesions, aunesions, appendectority, propsy, pyrorocentuali, biliary/bile duct calculi, benign and
rectal polyps of sigmoid colon, gall bladder calculi, billiary/bilde, verios, rectar polyps or sigmold onlyn, gittis, ulcers, angiodysplasia, hemorrholds, varioss, malignant neoplasm, polyps, collis, arooro, anglour, centric ulcer, duodenal ulcer, non-Csophaghis, coophagoar 4/001, colorectal cancer, gastritis, bleeding tumors, blecomig dicer, gastho ordermations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery
The Er: YAG is intended for the surgical incision/excision, vaporization and The ET. TAG Intended for the Surgiountinents and general surgery application where skin incision, coagulation of son assue daring any gumors and lesions, complete or partial (1550 also and internal organs, tumors, tissue ablation and/or vessel coagulation. Genitourinary/Urology
Genitounnary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder tumors; invasive bladder carcinomas; urethral and penile hemangiorna; urethral strictures; lesions of the external genitalia, condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Oral/Maxillofacial
Indications include oral/dental procedures for incision, excision, ablation, vaporization moreators molade ording proog gingivoplasties, gingivectomies, frenectornies, and fiernostation of out lesion removal, biopsies, leukoplakia and fibrotomy.
4
Otorhinolaryrigological (ENT) Surgery
Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate mocedures (e.g. turbinoplasty, turbinectorny), dacryocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty. Podiatry Indications include warts, plantar verruae, large mosaic verrucae and matrixectorny, Pulmonary Surgery Open and endoscopic pulmonary surgery. Thoracic Surgery Intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.
Pulsed Light (300-1400 nm) Indications for Use:
I he Profile Multi-Platform Systems and Accessories are indicated for use in surgical, assthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for
- · The treatment of tattoos; (560nm LP filter, 590nm LP filter)
- · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filler, 560nm I_P filter)
- · The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter)
- · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations:
(560nm LP filter, 590nm LP filter)
- · (Soom/FEF-Jikor, Sovis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis: (350nm BP filter)
- · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
(590nm LP filter, 640nm LP filter, 695 LP filter)
-
· Mild to moderate inflammatory and pustular inflammatory acne vulgaris. (420mm BP filter, 515nm LP filter, 560 LP filter)
The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: -
· Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
-
· Reduce discomfort during and/or associated with light or laser treatment,
-
· Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation:
-
Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
-
· Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).
The Profile Multi-Platform System shares the same indications for use, similar design free i res (including wavelength, laser/light medium and delivery systems, power supply, cooling and control system), functional features (including power output, repetition rate, energy, spot size and fluence), and is therefore substantially equivalent to the above legally marketed predicate devices
Safety and
Technological
Characteristics
The indications for use are based upon the indications for use for predicate systems.
5
Effectiveness
Conclusion
Technologically, the Profile Multi-Platform System is substantially equiralent to the Technologically, the Profile Mall Plater Plater Fits and benefits for the Profile Multi-Piatform System are comparable to the predicate devices.
The Profile Multi-Platform System shares similar indications for use, design features, The Fronte Mana-Flational features as, and therefore is substantially equivalent to, the currently marketed predicate devices.
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2006
Sciton, Inc. c/o Mr. Jay M. Patel Vice President of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303
Re: K060033
Trade/Device Name: Profile Multi-Platform System 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: January 4, 2006 Received: January 10, 2006
Dear Mr. Patel:
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 r ou may, after or visions 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 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.
7
Page 2 - Mr. Patel
This letter will allow you to begin marketing your device as described in your Scction 510(k) This letter will anow you to ogin manetaly your and equivalence of your device to a legally premarket nourceation: "The sults 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 If you desire specific acries in 15. Jour 15. Also, please note the regulation entitled, Colliation of Compilance in the market notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on Jour responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
el.mee
Mark N. Melkerson, M.S Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Attachment III
Statement of Indications for Use
510(k) Number (if known): K060033
Device Name: _________________________________________________________________________________________________________________________________________________________________
Profile Multi-Platform System
Indications for Use:
1064 nm Indications for Use:
The Profile Multi-Piatform Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopicllaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.
The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal
| Prescription Use
| (Per 21CFR801) | ✓ |
|---|---|
| OR Over-The-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
el Mall
(Division Sign-Off)
Division of General, Restorative.
and Neurological Devices
Page 1 of 5
| 510(k) Number | K060033 |
|---|---|
| --------------- | --------- |
9
protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
1320 nm Indications for Use;
The Profile Multi-Platform Systems and Accessories are intended for use in general surgery and dematology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.
Profile 2000 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications:
Dermatology and Plastic Surgery
Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization, Gastroenterological/Gastrointestinal Surgery
Open and endoscopic gastroenterologic surgery of soft tissue(for incision, excision, resection, ablation, vaporization, coagulation and hernostasis) including;
cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotorny, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, uicers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding furnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Oster-Weber-Rendu disease.
General Surgery
General surgery of soft tissues, including; skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectorny, hepatectorny, pancreatectorny, splenectorny, thyroidectorny, parathyroidectorny, herniorthaphy, tonsillectorny, lymphadenectorny, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectorny, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectomy. Genitourinary Surgery/Urology
Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions.
Page 2 of 5
ell.mall. K06007
10
Endoscopic transurethral incision of prostate, ablation of benign prostatic hypertrophy, transurethral incision of prostate, laser resection of the prostate, laser enuculeation of the prostate, laser ablation of the prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynecological Surgery
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, including condyloma acuminate, intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septurn by incision, excision, ablation and or vessel coagulation, soft tissue excision procedures such as excisional conization of the cervix. Lithotripsy and Percutaneous Urinary Lithotripsy
Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. Lumbar Discectorny
Lumbar discectorny in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy.
Orthopedic Surgery and Arthroscopy
Orthopedic surgery in soft and catiliaginous tissue in small and large joints, including. knee meniscectorny, knee synovectorny, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectorny in the knee, chondroplasty in the knee, chondromalacia ablation, ablation of soft and cartilaginous tissue in minimal invasive spinal surgery including percutaneous laser disc decompression/ discectorny, foraminoplasty, ablation and coaqulation of soft vascular and non-vascular tissue in minimally invasive spinal surgery.
Otorhinolaryrigological (ENT) Surgery
Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue. including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectorny), dacı yocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy,
sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty, lesions or turnors of the oral, nasal, glossal, pharyngeal, tonsillectomy, adenoidectorny, adenoidectorny. Thoracic and Pulmonary Surgery
Open and endoscopic thoracic and pulmonary surgery (incision, resection, ablation. vaporization, coagulation and hernostasis) of soft tissue, including laryngeal lesions, airway obstructions including carcinoma, polyps and granulomas, palliation of obstructing carcinomas of the tracheobroncial tree.
2940 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Page 3 of 5
El. mell. K060033
11
Dental Application of Er: YAG
It is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.
Hard Tissue Indications of Er. YAG Laser Energy: Caries removal, cavity preparation, enamel etching, enameloplasty, excavation of pits and fissures for placement of sealant.
Scallant.
Bone Indications of ETYAG Laser Energy. Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue, apicoectorny, osseous crown lengthening, culting bone to prepare a window access to the apex of the root, osseoplasty, osteotomy.
Soft Tissue and Periodontal Indications of Er.YAG Laser Energy. Excisional and incisional biopsies, exposure of unerrupted teeth, incision and drainage of abscesses, gingival incision and excision, gingivoplasties, gingivectomies, gingivectorny in case gingwal mondow of the gingival or excision of hyperplasias, gingival troughing for or nyperplasias of the girls of the start recovery, frenectomies and frenotomies, fibromatosis, benign and malignant lesion removal, operculectorny, oral papillectornies, reduction of gingival hypertrophy, soft tissue crown lengthening, papilletin surgery (flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibrormatoses, benign growths), vestibuloplasty,
sucular debridement
Endodontal Applications of Er.YAG Laser Energy: Tooth preparation to obtain access to root canal, pulpotomy, pulpotomy as an adjunct to root canal therapy, pulp extirpation, root canal debridement and cleaning, root canal preparation including enlargement.
Dermatology & Plastic Surgery
Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation.
Gastroenterology
Gastroenterologic surgery of soft tissue, including: cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, nonbleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding turnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery
The Er: YAG is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation. Genitourinary/Urology
Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder turnors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynocology
Indications include cervical intracpithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology
Optimalitions include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Oral/Maxillofacial
Indications include oral/dental procedures for incision, excision, ablation, vaporization mulations more of soft tissue during gingivoplasties, gingivectornies, frenectomies,
Page 4 of 5
dl.mall.
12
benign and malignant lesion removal, biopsies, leukoplakia and fibrotorny, Otorhinolaryrigological (ENT) Surgery Otominolaryngological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate including. Chaosinus ourgery, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty. Podiatry Indications include warts, plantar verruae, large mosaic verrucae and matrixectorny. Pulmonary Surgery Open and endoscopic pulmonary surgery. Thoracic Surgery Thoracic Surgery
Intended for the surgical incision/excision, vaporization and coagulation of soft tissue
Pulsed Light (300-1400 nm) Indications for Use:
during any thoracic surgery.
The Profile Multi-Platform Systems and Accessories are indicated for use in surgical. aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for.
- · The treatment of tattoos;
- (560nm LP filter, 590nm LP filter)
- · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP fifter, 560nm LP fifter)
- · The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter)
- · The treatment of benign cutaneous vascular lesions, including port wine stains, The treathern of beliginical and leg telangiectasias, rosacea, erytherna of rosacea, angiomas and spider angiomas, poikilodema of Civatte, leg veins and venous malformations; (580nm LP filter, 590nm LP filter)
- · Treatment of psociasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, (350nm BP filter)
- · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
- (590nm LP filter, 640nm LP filter, 695 LP filter)
- · Mild to moderate inflammatory and pustular inflammatory acne vulgaris, (420nm BP filter, 515nm LP filter, 560 LP filter)
The integral thermo-electric cooler is indicated for use in cooling the epidemis at the r the integral them of during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
- · Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
- · Reduce discomfort during and/or associated with light or laser treatment:
- · Ninimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
- · Allow the use of higher light or laser fluences for light or laser treatments (such Allow the use of mgner light of the treatment of vascular or pigmented lesions); and
- as for hair removal and the a suarront of laser treatments (such as for hair removals and the treatment of vascular or pigmented lesions).
Page 5 of 5