510(k) · Cleared

Cleared

Ruby Star

K150997510(k) TraditionalCleared Dec 22, 2015251-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

Bison Medical Co, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Dec 22, 2015 as substantially equivalent to K990902 (Medical Laser Technologies, Ltd., 1999) after a 251-day review. Its family tree reaches back 2 generations to 1998.

Decided: Dec 22, 2015
Review: 251 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K980187 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK980187 MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 1998
1 generation backK990902 Modification of MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 1999
This deviceK150997 Ruby StarBison Medical Co, Ltd. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K980187	MLT R694 Ruby Laser System	Medical Laser Technologies, Ltd.	1998	—
−1	K990902	Modification of MLT R694 Ruby Laser System	Medical Laser Technologies, Ltd.	1999	—
0 (this device)	K150997	Ruby Star	Bison Medical Co, Ltd.	2015	—

FIG. 1 — Lineage of K150997, 1998–2015Source: 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
*	K990902	Modification of MLT R694 Ruby Laser System Summary page 4 …Class II Classification Panel : General and Plastic Surgery. Product Code : GEX 4. Legally marketed Predicate Device K990902 MLT R694 Medical laser Technologies All characteristics such as Design, Construction, En…	Medical Laser Technologies, Ltd.	1999	—

Also cleared against K990902: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K990902.

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. 2015, 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?

RUBY STAR Laser Q -switched 694nm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150997 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150997: Ruby Star.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150997

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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