# K971539: Novatip Family of Laser Handpiece Tips

- Pathway: 510(k) (Traditional)
- Applicant: Xanova Corp.
- Decided: Jun 3, 1997 after 36 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953074 (1995). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960475: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1996) Summary page 1.

## Most influential descendants
- K993942: Litesaber 2000 (2000), 1 descendant of its own
- K082445: CURATIVE980 Diode Laser (2008), 0 descendants of its own

## Indications for use
The intended use of the Xanova tips is to comprise the distal end element of a surgical CO; laser beam delivery system for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use in various specialties are listed below. Gynecology—excision and vaporization of cervical, vulvar, and perineal condyloma; ablation. of vaginal and vulvar-intraepithelial neoplasia; he.pes vaporization; vaporization of urethral caruncle; I&D Bartholin’s and nubothian cysis. Dermatology—port wine hemangioma removal, rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis. Dentistry/Oral Surgery—gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors. General Surgery—hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures. Otorhinolaryngology—lymphangioma removal; turbinectomy. Podiatry—plantar wart vaporization, fungal nail treatment; partial and complete matrixéctomy; porokeratoma ablation; Morton’s neuroma removal; ingrown toenail treatfitent.

Source page: https://510kreport.com/device/K971539
Methodology: https://510kreport.com/methodology