(149 days)
Not Found
No
The document describes a surgical laser system and its accessories for soft tissue procedures. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, decision support, or automated control beyond standard laser operation.
Yes
The device is indicated for surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue in various medical specialties, which are therapeutic interventions.
No
Explanation: The device is a surgical laser designed for tissue modification (ablation, vaporization, excision, incision, coagulation), not for identifying or investigating disease.
No
The device description explicitly lists multiple hardware components including a laser console and tower, articulated arm, control panels, footswitch, handswitch, remote control, air pump, and various delivery accessories. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The device description details a surgical laser system with components designed for delivering light energy for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (within the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery.
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective when indicated for use in specific surgical applications including:
Dermatology & Plastic Surgery
- Ablation, vaporization, excision, incision, and coagulation of soft tissue in ● dermatology and plastic surgery (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces) in the performance of laser skin resurfacing and laser derm-abrasion (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces), and laser burn debridement.
- Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic . surgery using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces for the treatment of wrinkles, rhytids, and furrows.
- Laser skin resurfacing (ablation and/or vaporization) of soft tissue in . dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).
Dermatology, Plastic Surgery and General Surgery
- Laser incision and/or excision of soft tissue in dermatology, plastic and general . surgery for the performance of blepharoplasty.
- Laser incision and/or excision of soft tissue in dermatology, plastic and general . surgery for the creation of recipient sites for hair transplantation.
Podiatry
- Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the . reduction, removal, and/or treatment of verrucae vulgares (warts)
- Laser ablation, vaporization, and/or excision in podiatry for matrixectomy. .
Otorhinolarıngology (ENT)
- Laser incision, excision, ablation and/or vaporization of soft tissue in . otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, adult and juvenile papillomatosis polyps, rhinophyma, and verrucae vulgares (warts).
Gynecology
- . Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies), and vulvar and vaginal intraepithelial neoplasia
Neurosurgery
- . Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
Product codes
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Device Description
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (and its delivery accessories) are intended to be used to deliver carbon dioxide light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a variety of medical specialties.
Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are comprised of the following main components:
- a laser console and tower; .
- a counterbalanced articulated arm and delivery system; .
- . control and display panels;
- . footswitch and handswitch delivery controls;
- a remote control unit;
- a filtered air pump purge system; and ●
- a variety of delivery device accessories (handpieces, scanners, waveguides, ● micromanipulators, optical couplers and laparoscopic adapters, and insufflation and purge gas systems).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, larynx, nose, cervix, vulva, vagina, basal tumor, posterior fossa, peripheral nerves, lips.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the ULTRAPULSE CO2 laser increases the amount of sub-epidermal collagen.
Clinical studies (1, 2, 3, 4, 5, 6) demonstrated that CO2 laser blepharoplasty provides cosmetic results that are equivalent to cold steel blepharoplasty, is up to 33% faster than cold steel blepharoplasty, provides good hemostasis and visualization of the surgical field, and results in less ecchymosis, edema, and bruising when compared to cold steel.
Clinical studies (7, 8, 9, 10) demonstrated that the use of ULTRAPULSE CO2 surgical lasers, as compared to cold steel, results in faster operative times, reduced bleeding, no compression of laser created sites (due to removal of scalp tissue vaporized from laser created sites), and greater hair density (due to removal of scalp tissue vaporized from laser created sites).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951812, K912029, K946304, K853620, K960521, K955621
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
Attachment 15 510(k) Summary Statement for K963339 the Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers
General Information I.
| Submitter: | JAN 22 1997 |
|---|---|
| Coherent Medical Group | |
| 3270 West Bayshore Road | |
| Palo Alto, CA 94303 |
Contact Person: Anne C. Worden
Summary Preparation Date: Revised November 27, 1996
II. Names
Coherent ULTRAPULSE Family of Carbon Dioxide Surgical Lasers Device Names: and Delivery Accessories.
Powered Surgical Instrument Primary Classification Name: Laser (and Accessories).
III. Predicate Devices
- Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and Delivery Accessories . (K951812 & K912029) marketed by Coherent Medical Group;
- Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE . Carbon Dioxide Surgical Lasers (K946304) marketed by Coherent Medical Group;
- Coherent Xanar XA-50 Carbon Dioxide Surgical Laser (K853620) marketed by . Coherent / Xanar
- Sharplan Carbon Dioxide SilkLaser with FeatherTouch and SilkTouch (510(k) ● cleared November 4, 1996 - K number unknown, K960521, & K955621)
IV. Product Description
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (and its delivery accessories) are intended to be used to deliver carbon dioxide light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a variety of medical specialties.
Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are comprised of the following main components:
- a laser console and tower; .
- a counterbalanced articulated arm and delivery system; .
- . control and display panels;
- . footswitch and handswitch delivery controls;
- a remote control unit;
- a filtered air pump purge system; and ●
- a variety of delivery device accessories (handpieces, scanners, waveguides, ● micromanipulators, optical couplers and laparoscopic adapters, and insufflation and purge gas systems).
1
V. Indications for Use
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery.
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective when indicated for use in specific surgical applications including:
Dermatology & Plastic Surgery
- Ablation, vaporization, excision, incision, and coagulation of soft tissue in ● dermatology and plastic surgery (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces) in the performance of laser skin resurfacing and laser derm-abrasion (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces), and laser burn debridement.
- Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic . surgery using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces for the treatment of wrinkles, rhytids, and furrows.
Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the ULTRAPULSE CO2 laser increases the amount of sub-epidermal collagen.
- Laser skin resurfacing (ablation and/or vaporization) of soft tissue in . dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).
Dermatology, Plastic Surgery and General Surgery
- Laser incision and/or excision of soft tissue in dermatology, plastic and general . surgery for the performance of blepharoplasty.
Clinical studies1, 2, 3, 4,5 ,6 demonstrate that CO2 laser blepharoplasty provides cosmetic results that are equivalent to cold steel blepharoplasty, is up to 33% faster than cold steel blepharoplasty, provides good hemostasis and visualization of the surgical field, and results in less ecchymosis, edema, and bruising when compared to cold steel.
Morrow, D .; Morrow L. CO2 Blepharoplasty: A Comparison with Cold-Steel Surgery J Dermatol Surg 1. Oncol 1992: 18:307-313.
David, L. The Laser Approach to Blepharoplasty J Dermatol Surg Oncol 1988; 14:7:741-746.
- David, L .; Sanders G. CO2 Laser Blepharoplasty: A Comparison to Cold Steel and Electrocatery ] Dermatol Surg Oncol 1987; 13:2:110-114.
Baker, S.; Muenzler, W.; Small, R.; Leonard, J. Carbon Dioxide Laser Blepharoplasty Ophthalmology 4. 1984; 91:238-244
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David, L .; Abergel, R. CO2 Laser Blepharoplasty Cosmetic Surgery of the Skin: Principles and Techniques, B.C. Decker, Philadelphia, PA, 1991, Chapter 15:295-300.
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Glassberg, E .; Babapour, R .; Lask, G. Current Trends in Laser Blepharoplasty Dermatol Surg 1995; 21:1060-1063.
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- V. Indications for Use Continued
Dermatology. Plastic Surgery and General Surgery - Continued
- Laser incision and/or excision of soft tissue in dermatology, plastic and general . surgery for the creation of recipient sites for hair transplantation.
Clinical studies7, 8, 9, 10 demonstrate that the use of ULTRAPULSE CO2 surgical lasers, as compared to cold steel, results in faster operative times, reduced bleeding, no compression of laser created sites (due to removal of scalp tissue vaporized from laser created sites), and greater hair density (due to removal of scalp tissue vaporized from laser created sites).
Podiatry
- Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the . reduction, removal, and/or treatment of verrucae vulgares (warts)
- Laser ablation, vaporization, and/or excision in podiatry for matrixectomy. .
Otorhinolarıngology (ENT)
- Laser incision, excision, ablation and/or vaporization of soft tissue in . otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, adult and juvenile papillomatosis polyps, rhinophyma, and verrucae vulgares (warts).
Gynecology
- . Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies), and vulvar and vaginal intraepithelial neoplasia
Neurosurgery
- . Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
Unger, W. Laser Hair Transplantation II Dermatol Surg 1995; 21:759-765. 7.
Fitzpatrick, R. Laser Hair Transplantation - Tissue Effects of Laser Parameters Dermatol Surg 1995; 8. 21:1042-1046
-
Ho. C.; Nguyen, Q .; Lask, G .; Lowe, N. Mini-Slit Graft Hair Transplantation Using the Ultrapulse Carbon Dioxide Laser Handpiece Dermatol Surg 1995; 21:1056-1059.
-
Unger, W .; David, L. Laser Hair Transplantation | Dermatol Surg Oncol 1994; 20:515-521.
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Rationale for Substantial Equivalence VI.
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and their delivery device accessories share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to the Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K912029), the Coherent Family of Scanner Handpieces (K946304), the Coherent Xanar XA-50 Carbon Dioxide Surgical Laser (K853620), and to the CO2 SilkLaser with FeatherTouch and SilkTouch Flash Scanners, marketed by Sharplan Lasers, Inc (510(k) cleared November 4, 1996 - K number unknown, K960521, and K955621). In addition, clinical data demonstrated that the Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective when indicated for use for additional specific applications in a variety of medical specialties.
VII. Safety and Effectiveness Information
Clinical data was provided to demonstrate that the Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective, when indicated for use for specific applications in the medical specialties of dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); and general surgery.
VIII. Conclusion
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers were found to be substantially equivalent to similar currently marketed and predicate surgical laser devices. The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers share the same indications for use, similar design features, and similar functional features as the currently marketed Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and delivery devices, and are substantially equivalent to the Coherent Xanar XA-50 and the Sharplan SilkLaser (with FeatherTouch and SilkTouch Flash Scanners).
Clinical study results demonstrated Coherent ULTRAPULSE CO2 Surgical Lasers are safe and effective for use in a variety of specific indications for use in a variety of medical specialties including dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); and general surgery.