510(k) · Cleared

Cleared

50W Ceralas D 1950NM Diode Laser

K072682510(k) TraditionalCleared Apr 18, 2008210-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

Biolitec, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Apr 18, 2008 as substantially equivalent to K033423 (Allmed Systems, Inc., 2004) and 2 other predicates after a 210-day review. Its family tree reaches back 1 generation to 2004. 194 later devices descend from it.

Decided: Apr 18, 2008
Review: 210 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K033423 (2004). 3 ancestors in all. 194 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK033423 Revolix Laser SystemsAllmed Systems, Inc. · 2004
This deviceK072682 50W Ceralas D 1950NM Diode LaserBiolitec, Inc. · 2008
Descendant · cites it directly · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Descendant · cites it directly · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 2 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010

Showing 5 of 194 descendants. See all descendants

Descendants cleared per year

2008high 26 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 194 · See all

K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · cites it directly192descendants
K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · cites it directly112descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 2 generations on68descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033423	Revolix Laser Systems	Allmed Systems, Inc.	2004	—
0 (this device)	K072682	50W Ceralas D 1950NM Diode Laser	Biolitec, Inc.	2008	—
+1	K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	—
+1	K082230	Vectra Plus Laser System and Accessories	Xintec Corporation	2010	—
+2	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+3	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+2	K100558	Quanta Diode Laser System	Quanta System Spa	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	6	0
2011	4	0
2012	4	0
2013	7	0
2014	8	0
2015	10	0
2016	10	0
2017	6	0
2018	11	0
2019	7	0
2020	14	0
2021	9	0
2022	23	0
2023	11	0
2024	22	0
2025	26	0
2026	15	0

FIG. 1 — Lineage of K072682, 2004–2026Source: 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? (3)

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
*	K033423	Revolix Laser Systems Summary page 1 …Laser, Surgical Diode Laser System Product Code and Regulation Number GEX, 21 C.F.R. 878.4810 Predicate Devices AllMed Revolix 120 Laser Systems (K033423, K051167, K070476) Intended Use / Indications for Use Urology Open and endoscopic surgery (incision, excision, r…	Allmed Systems, Inc.	2004	—
*	K051167	Revolix and Revolix JR Summary page 1 …aser, Surgical Diode Laser System Product Code and Regulation Number GEX, 21 C.F.R. 878.4810 Predicate Devices AllMed Revolix 120 Laser Systems (K033423, K051167, K070476) Intended Use / Indications for Use Urology Open and endoscopic surgery (incision, excision, resection,…	Allmed Systems, Inc.	2005	—
*	K070476	Revolix 120 Summary page 1 …gical Diode Laser System Product Code and Regulation Number GEX, 21 C.F.R. 878.4810 Predicate Devices AllMed Revolix 120 Laser Systems (K033423, K051167, K070476) Intended Use / Indications for Use Urology Open and endoscopic surgery (incision, excision, resection, ablation…	Allmed Systems, Inc.	2007	—

What descends from it? (194)

See all 194

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

Number	Device	Applicant	Decided	Descendants
K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	192
K082230	Vectra Plus Laser System and Accessories	Xintec Corporation	2010	112
K100726	Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…	Biolitec, Inc.	2010	54

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?

None of the 3 ancestors has a recall.
Of its descendants, K083613 (Quanta System Spa, 2008) has gone furthest, with 192 descendants of its own.

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. 2008, this device’s year, is highlighted.

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?

Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: · Urethral strictures · Bladder neck incisions · Ablation and resection of bladder tumors, urethral tumors and ureteral tumors · Ablation of Benign Prostatic hypertrophy (BPH) · Transurethral incision of the prostate (TUIP) * Laser Resection of the Prostate (HoLRP) * Laser Enucleation of the Prostate (HoLEP) · Laser Ablation…

Read the full statement (452 words)

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization,

coagulation and hemostasis) including:

· Urethral strictures

· Bladder neck incisions

· Ablation and resection of bladder tumors, urethral tumors and

ureteral tumors

· Ablation of Benign Prostatic hypertrophy (BPH)

· Transurethral incision of the prostate (TUIP)

* Laser Resection of the Prostate (HoLRP)

* Laser Enucleation of the Prostate (HoLEP)

· Laser Ablation of the Prostate (HoLAP)

· Condylomas

* Lesions of the external genitalia

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation,

vaporization, coagulation and hemostasis) including:

Appendectomy

Polyps

Biopsy

Gall Bladder calculi

Biliary/bile duct calculi

Ulcers

Gastric ulcers

*Duodenal ulcers

Non-bleeding ulcers

Pancreatitis

Hemorrhoids

Cholecystectomy

Benign and malignant neoplasm

Angiodysplasia

Colorectal cancer

Telangiectasias

Telangiectasias of the Osler-Weber-Renu disease

Vascular malformation

Gastritis

Esophagitis

Esophageal ulcers

Varices

Colitis

Mallory-Weiss tear

Gastric erosions

Thoracic/Pulmonary Surgery

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection,

ablation, vaporization, coagulation and hemostasis) including

· Laryngeal lesions

· Airway obstruction including carcinoma

* Polyps and granulomas

· Palliation of obstructing carcinomas of the tracheobronchial tree

Gynecology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization,

coagulation and hemostasis) including

* Intra-uterine treatment of submucous fibroids, benign

endometrial polyps and uterine septum by incision, excision,

ablation and or vessel coagulation

Soft tissue excision procedures such as excisional conization of

the cervix

Ear, Nose and Throat (Otolaryngology)

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization,

coagulation and hemostasis) including:

• Endonasal/sinus surgery

• Partial turbinectomy

* Polypectomy

* Dacryocystorhinostomy

* Frontal sinusotomy

* Ethmoidectomy

· Maxillary antrostomy

· Functional endoscopic sinus surgery

· Lesions or tumors of the oral, nasal, glossal, pharyngeal and

laryngeal

* Tonsillectomy

* Adenoidectomy

Dermatology/Plastic Surgery

Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of

soft, mucosal, fatty and cartilaginous tissue in therapeutic plastic, dermatologic and

aesthetic procedures including:

· Basal Cell carcinomas

· Lesions of the skin and subcutaneous tissue

* Skin tags

* Plantar warts

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and

cartilaginous tissue)

* Ablation of soft and cartilaginous tissue in minimally invasive

spinal surgery including:

: Percutaneous laser disc decompression/discectomy

--- Foraminoplasty

Ablation and coagulation of soft vascular and non

vascular tissue

General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation,

vaporization, coagulation and hemostasis) including:

* Cholecystecomy

* Lysis of adhesions

• Appendectomy

* Biopsy

* Skin incision

* Tissue dissection

* Excision of external tumors and lesions

* Complete or partial resection of internal organs, tumors and lesions

* Mastectomy

* Hepatectomy

* Pancreatectomy

* Splenectomy

* Thyroidectomy

* Parathyroidectomy

* Herniorrhaphy

* Tonsillectomy

* Lymphadenectomy

* Partial nephrectomy

* Pilonidal Cystectomy

* Resection of lipoma

* Debridement of decubitus ulcers

* Hemorrhoids

* Debridement of statis ulcers

· Biopsy

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/K072682 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072682: 50W Ceralas D 1950NM Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072682

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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