510(k) · Cleared

Cleared

Novatip Family of Laser Handpiece Tips

K971539510(k) TraditionalCleared Jun 3, 199736-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Xanova Corp. · GEX Powered Laser Surgical Instrument

Cleared on Jun 3, 1997 as substantially equivalent to K960475 (Luxar Corp., 1996) after a 36-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.

Decided: Jun 3, 1997
Review: 36 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K953074 (1995). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
1 generation backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
This deviceK971539 Novatip Family of Laser Handpiece TipsXanova Corp. · 1997
Descendant · cites it directly · 1 of its ownK993942 Litesaber 2000Laser Dental Innovations · 2000
Descendant · 2 generations on · 0 of its ownK082445 CURATIVE980 Diode LaserOroscience, Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all

K993942Litesaber 2000Laser Dental Innovations · 2000 · cites it directly1descendant
K082445CURATIVE980 Diode LaserOroscience, Inc. · 2008 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K953074	Modified Luxar LX-20 Family CO2 Laser System	Luxar Corp.	1995	—
−1	K960475	Modified Luxar LX-20 Family CO2 Laser System	Luxar Corp.	1996	—
0 (this device)	K971539	Novatip Family of Laser Handpiece Tips	Xanova Corp.	1997	—
+1	K993942	Litesaber 2000	Laser Dental Innovations	2000	—
+2	K082445	CURATIVE980 Diode Laser	Oroscience, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2008	1	0

FIG. 1 — Lineage of K971539, 1995–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K960475	Modified Luxar LX-20 Family CO2 Laser System Summary page 1 …l laser 6. Legally marketed predicate devices used for equivalency: Luxar laser handpiece tips models LXT-C5, LXT-C10, LXT-005TSS, LXT-120ST, LXNS-T3, as cleared under K960475 Luxar Modified CO, Surgical Laser System 7. Description: The Xanova Novatips constitute the disposable end element of the hollow…	Luxar Corp.	1996	—

Also cleared against K960475: 7 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993942	Litesaber 2000	Laser Dental Innovations	2000	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K993942 (Laser Dental Innovations, 2000) has gone furthest, with 1 descendant of its own.
7 other devices also cite its predicate K960475.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

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…

Read the full statement (167 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971539 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971539: Novatip Family of Laser Handpiece Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971539

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026