510(k) · Cleared

Cleared

Twilight

K991994510(k) TraditionalCleared Sep 10, 199988-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

Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Sep 10, 1999 as substantially equivalent to K954316 (Premier Laser Systems, Inc., 1995) and 5 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1992. 280 later devices descend from it.

Decided: Sep 10, 1999
Review: 88 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K922901 (1992). 7 ancestors in all. 280 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
1 generation backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
This deviceK991994 TwilightBiolase Technology, Inc. · 1999
Descendant · cites it directly · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
Descendant · 2 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
Descendant · 3 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
Descendant · 4 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · 5 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008

Showing 5 of 280 descendants. See all descendants

Descendants cleared per year

2002high 32 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 280 · See all

K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · cites it directly246descendants
K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 2 generations on240descendants
K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 3 generations on226descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 4 generations on221descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 5 generations on202descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K922901	Incisor I Pulsed ND:Yag Laser System	Buckman Co., Inc.	1992	—
−1	K972325	Pulsemaster 1000 ST Dental Laser System	American Dental Technologies, Inc.	1997	—
0 (this device)	K991994	Twilight	Biolase Technology, Inc.	1999	—
+1	K012511	Waterlase Millennium	Biolase Technology, Inc.	2002	—
+2	K021508	Opusduo EC Dental Laser System	Opusdent, Ltd.	2002	—
+3	K040270	Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum	Lumenis, Ltd.	2004	—
+4	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+5	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	1	0
1998	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2004	2	0
2006	3	0
2007	5	0
2008	14	0
2009	5	0
2010	11	0
2011	8	0
2012	5	0
2013	11	0
2014	11	0
2015	13	0
2016	11	0
2017	9	0
2018	15	0
2019	8	0
2020	17	0
2021	12	0
2022	26	0
2023	15	0
2024	26	0
2025	32	0
2026	19	0

FIG. 1 — Lineage of K991994, 1992–2026Source: 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

Get a 510(k) Report

What was it cleared against? (6)

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
*	K954316	Aurora Surgical Diode Laser System W/Accessories Summary page 2 …aterials or specifications presented herein. Twilight™ is identical to several other diode laser systems cleared by the FDA. Equivalent devices include: Premier, Aurora™(K954316), American Dental Technologies, PulseMaster™ (K972325) and Dentek, LD-15 ™ (K974057) for general dental soft tissue applications,…	Premier Laser Systems, Inc.	1995	—
*	K972325	Pulsemaster 1000 ST Dental Laser System Summary page 2 …is identical to several other diode laser systems cleared by the FDA. Equivalent devices include: Premier, Aurora™(K954316), American Dental Technologies, PulseMaster™ (K972325) and Dentek, LD-15 ™ (K974057) for general dental soft tissue applications, Premier, Aurora™ (K981379) for pulpotomy and American…	American Dental Technologies, Inc.	1997	—
*	K974057	Dentek LD 15 Lasersystem Summary page 2 …diode laser systems cleared by the FDA. Equivalent devices include: Premier, Aurora™(K954316), American Dental Technologies, PulseMaster™ (K972325) and Dentek, LD-15 ™ (K974057) for general dental soft tissue applications, Premier, Aurora™ (K981379) for pulpotomy and American Dental Technologies, PulseMas…	Dentek Lasersystems Produktions Ges.M.B.H.	1998	—
*	K981379	Aurora Summary page 2 …mier, Aurora™(K954316), American Dental Technologies, PulseMaster™ (K972325) and Dentek, LD-15 ™ (K974057) for general dental soft tissue applications, Premier, Aurora™ (K981379) for pulpotomy and American Dental Technologies, PulseMaster™ (K961269) and Premier, Aurora™ (K974586) for sulcular debridement.…	Premier Laser Systems, Inc.	1998	—
*	K961269	Pulsemaster Summary page 2 …2325) and Dentek, LD-15 ™ (K974057) for general dental soft tissue applications, Premier, Aurora™ (K981379) for pulpotomy and American Dental Technologies, PulseMaster™ (K961269) and Premier, Aurora™ (K974586) for sulcular debridement. Conclusion: Twilighf™ is substantially equivalent to several available…	American Dental Technologies, Inc.	1997	—
*	K974586	Aurora Diode Laser System Summary page 2 …057) for general dental soft tissue applications, Premier, Aurora™ (K981379) for pulpotomy and American Dental Technologies, PulseMaster™ (K961269) and Premier, Aurora™ (K974586) for sulcular debridement. Conclusion: Twilighf™ is substantially equivalent to several available, established dental diode lase…	Premier Laser Systems, Inc.	1998	—

Also cleared against K954316: 6 other devices →

What descends from it? (280)

See all 280

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012511	Waterlase Millennium	Biolase Technology, Inc.	2002	246
K083069	Ezlase 10W	Biolase Technology, Inc.	2008	36
K063384	Diodent Micro Dental Laser System, Models 810 and 980	Hoya Conbio, Inc.	2007	13

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 7 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K012511 (Biolase Technology, Inc., 2002) has gone furthest, with 246 descendants of its own.
6 other devices also cite its predicate K954316.

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?

Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples: Removal of beningn lesions from ear, nose and throat. Excision and vaporization of vocal cord nodules and polyps. Incision and excision of carcinoma in-situ. Ablation and vaporization of kyperkeratosis. Excision of carcinoma of the larynx. Laryngeal…

Read the full statement (362 words)

Ear, Nose and Throat and Oral Surgery:

Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity.

Examples:

Removal of beningn lesions from ear, nose and throat.

Excision and vaporization of vocal cord nodules and polyps.

Incision and excision of carcinoma in-situ.

Ablation and vaporization of kyperkeratosis.

Excision of carcinoma of the larynx.

Laryngeal papillomectomy.

Excision and vaporization of herpes simplex I and II.

Arthroscopy:

Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery.

Examples:

Menisectomy

Synovectomy

Chondromalacia

Gastroenterology:

Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy.

Examples:

Hemostasis of upper and lower GI bleeding

Excision and vaporization of colorectal carcinoma

Excision of polyps

General Surgery, Dermatology & Plastic Surgery, and Podiatry:

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion.

Examples:

Matrixectomy

Excision of neuromas

Excision of periungual and subungual warts

Excision of plantar warts

Excision of Keloids

Liver resection

Excision of cutaneous lesions

Hemorrhoidectomy

Appendectomy

General Surgery, Dermatology & Plastic Surgery, and Podiatry (continues):

Examples:

Debridement of decubitus ulcer

Hepatobiliary

Mastectomy

Dermabrasion

Vaporization & hemostasis of capillary hemangioma

Excision, vaporization & hemostasis of abdominal tumors

Excision, vaporization & hemostasis of rectal pathology

Pilonidal cystectomy

Herniorraphy

Adhesiolysis

Parathyroidectomy

Laparoscopic cholecystecomy

Thyroidectomy

Resection of organs

GI/GU:

Excision, vaporization, and hemostasis of abdominal and rectal tissues.

Examples:

Hemorrhoidectomy

Excision, vaporization, and hemostasis of rectal pathology

Excision, vaporization, and hemostasis of abdominal tumors

Gynecology:

Ablation, excision, hemostasis and vaporization of tissue.

Examples:

Endometrial ablation

Excision or vaporization of condylomata acuminata

Vaporization of CIN (cervical intraepithelial neoplasia)

Cervical conization

Menorrhagia

Neurosurgery:

Hemostasis of tissue.

Example:

Hemostasis in conjunction with meningiomas

Ophthalmology:

Retinal photocoagulation

Diabetic retinopathy

Pulmonary Surgery:

Hemostasis, vaporization, and excision of tissue.

Examples:

Tracheobronchial malignancy or stricture

Pulmonary Surgery (continues):

Hemostasis, vaporization, and excision of tissue.

Examples:

Benign and malignant pulmonary obstruction

Urology:

Hemostasis, vaporization and excision of tissues.

Examples:

Vaporization of urethral tumors

Release of urethral stricture

Removal of bladder neck obstruction

Excision and vaporization of condyloma

Lesions of external genitalia.

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/K991994 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991994: Twilight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991994

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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

Twilight

Line of descent and top descendants

Other ancestors by year cleared

Descendants by year cleared

What was it cleared against? (6)

What descends from it? (280)

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

What does this lineage say?

How does its category compare?

What is it indicated for?

Also cleared against K954316

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