510(k) · Cleared

Cleared

Lucentlite, Model Imd 010

K033072510(k) TraditionalCleared Apr 1, 2004185-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

Industrial & Medical Design, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Apr 1, 2004 as substantially equivalent to K022226 (Altus Medical, Inc., 2002) and 3 other predicates after a 185-day review. Its family tree reaches back 7 generations to 1992.

Decided: Apr 1, 2004
Review: 185 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 4

Its longest line of descent runs back 7 generations to K910422 (1992). 79 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
2 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
1 generation backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
This deviceK033072 Lucentlite, Model Imd 010Industrial & Medical Design, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K910422	Model RD-1200 Ruby Laser System	Spectrum Medical Technologies, Inc.	1992	—
−6	K961279	Sharplan Lasers, Inc. Ruby Laser System	Sharplan Lasers, Inc.	1996	—
−5	K962446	Sharplan Ruby Laser System	Sharplan Lasers, Inc.	1997	—
−4	K974536	Photoderm HR System	Esc Medical Systems, Ltd.	1998	—
−3	K991935	Epilight Hair Removal System, Photoderm HR System	Esc Medical Systems, Ltd.	2000	—
−2	K014040	Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…	Altus Medical, Inc.	2002	—
−1	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…	Altus Medical, Inc.	2002	—
0 (this device)	K033072	Lucentlite, Model Imd 010	Industrial & Medical Design, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1988	1	0
1990	1	0
1991	4	0
1993	5	0
1994	8	0
1995	6	0
1996	7	0
1997	9	0
1998	6	0
1999	4	0
2000	6	0
2001	7	0
2002	7	0

FIG. 1 — Lineage of K033072, 1992–2004Source: 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? (4)

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
*	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future… Summary page 1 …- Device: Family of Altus Medical CoolGlide Aesthetic Lasers 5 10(k) K022226, K003202 - Company: CoolTouch Corporation - Device: CoolTouch Nd:YA…	Altus Medical, Inc.	2002	—
*	K003202	Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II Summary page 1 …- Device: Family of Altus Medical CoolGlide Aesthetic Lasers 5 10(k) K022226, K003202 - Company: CoolTouch Corporation - Device: CoolTouch Nd:YAG Laser S…	Altus Medical	2001	—
*	K014035	Cooltouch and Cooltouch-II ND:Yag Laser Systems Summary page 1 …- Company: CoolTouch Corporation - Device: CoolTouch Nd:YAG Laser System 510(k) K014035 - Company: Sciton, Inc. - Device: Profile 1320 Laser System…	Cooltouch Corp.	2002	—
*	K022466	Profile 1320 Laser System Summary page 1 …014035 - Company: Sciton, Inc. - Device: Profile 1320 Laser System 510(k) K022466 9-2 K033072 9.4. Device description. The Lucent…	Sciton, Inc	2002	—

Also cleared against K022226: 10 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 12 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
2 of the 79 ancestors have a recall of any class.
10 other devices also cite its predicate K022226.

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 LucentLite Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology: 1064 nm: - To effect stable long-term, or permanent* hair reduction through selective targeting of melanin in hair follicles. - For the removal of unwanted hair. - For coagulation and hemostasis of vascular lesions. - For…

Read the full statement (136 words)

1064 nm:

- To effect stable long-term, or permanent* hair reduction through selective targeting of melanin in hair follicles.

- For the removal of unwanted hair.

- For coagulation and hemostasis of vascular lesions.

- For Incision/excision of soft body tissues in dermatology.

- For soft tissue general surgery applications: skin incision; tissue dissection; excision of external tumors and lesions; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.

* Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after treatment regimen.

1320 nm:

- For the treatment of periorbital and perioral wrinkles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033072: Lucentlite, Model Imd 010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033072

Report an extraction error

Are you the manufacturer?

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