510(k) · Cleared

Cleared

Prolite Pulsed Light System

K021304510(k) TraditionalCleared Jul 23, 200290-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

Big Sky Laser Technologies, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 23, 2002 after a 90-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided: Jul 23, 2002
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK021304 Prolite Pulsed Light SystemBig Sky Laser Technologies, Inc. · 2002
Descendant · cites it directly · 0 of its ownK081095 Prolite Iii Tower and PR and HR HandpieceQuantel S.A. · 2008

Most influential descendants

Showing 1 of 1 · See all

K081095Prolite Iii Tower and PR and HR HandpieceQuantel S.A. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021304	Prolite Pulsed Light System	Big Sky Laser Technologies, Inc.	2002	—
+1	K081095	Prolite Iii Tower and PR and HR Handpiece	Quantel S.A.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K021304, 2002–2008Source: 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?

The FDA summary names no predicate by number.

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K081095	Prolite Iii Tower and PR and HR Handpiece	Quantel S.A.	2008	0

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?

Of its descendants, K081095 (Quantel S.A., 2008) has gone furthest, with 0 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.

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 ProLitem Pulsed Light System, equipped with the HR handpiece and 600 nanometer filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types. The ProLitem Pulsed Light System, equipped with the SR handpiece and 550 or 580 nanometer filters, is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow facial veins, telangiectasia, facial…

Read the full statement (141 words)

The ProLitem Pulsed Light System, equipped with the HR handpiece and 600 nanometer

filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types.

The ProLitem Pulsed Light System, equipped with the SR handpiece and 550 or 580

nanometer filters, is intended for the treatment of benign pigmented lesions and the

removal of tattoos, the treatment of vascular lesions, and the treatment of shallow facial

veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions

The 550 nanometer filter may be more efficient for Types I and 11 skin.

The 580 nanometer filter may be more efficient for Types I11 and IV skin.

The Center for Medical Devices and Radiological Health has concluded that the ProLitem

Pulsed Light System be labeled as a restricted device as follows:

“CAUTION: Federal (US) law restricts the use of this device to licensed professionals.”

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021304 · printed Nov 3, 2026

Cite this page

510(k) Report. “K021304: Prolite Pulsed Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021304

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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