510(k) · Cleared

Cleared

Schwartz Electro-Optics, Inc. Crystalase 755 DP Alexandrite Laser System

K980710510(k) TraditionalCleared May 22, 199887-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

Schwartz Electro-Optics, Inc. · GEX Powered Laser Surgical Instrument

Cleared on May 22, 1998 as substantially equivalent to K971737 (Cynosure, Inc., 1997) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1995.

Decided: May 22, 1998
Review: 87 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K950831 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK950831 AlexlazrCandela Laser Corp. · 1995
This deviceK980710 Schwartz Electro-Optics, Inc. Crystalase 755 DP Alexandrite Laser…Schwartz Electro-Optics, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950831	Alexlazr	Candela Laser Corp.	1995	—
0 (this device)	K980710	Schwartz Electro-Optics, Inc. Crystalase 755 DP Alexandrite Laser System	Schwartz Electro-Optics, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K980710, 1995–1998Source: 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? (2)

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
*	K971737	Cynosure Photogenica Lpir Dermatological Laser Summary page 1 …Optics, Inc. 3404 North Orange Blossom Trail Orlando, FL 32804 I, Model: Schwartz Electro-Optics, inc. CrystaLase 755 DP HI Predicate Cynosure, Inc. PhotoGenica LPIR (K971737), Candela Corp. AlexLazr (K950831) IV. Description: The Schwartz Electro-Optics, Inc. CrysteLase 755 DP System is a medical devi…	Cynosure, Inc.	1997	—
*	K950831	Alexlazr Summary page 1 …ssom Trail Orlando, FL 32804 I, Model: Schwartz Electro-Optics, inc. CrystaLase 755 DP HI Predicate Cynosure, Inc. PhotoGenica LPIR (K971737), Candela Corp. AlexLazr (K950831) IV. Description: The Schwartz Electro-Optics, Inc. CrysteLase 755 DP System is a medical device ‘ which is capable of emitting…	Candela Laser Corp.	1995	—

Also cleared against K971737: 7 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?

None of the 2 ancestors has a recall.
7 other devices also cite its predicate K971737.

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 Schwartz Electro-Optics, Inc. Crystalase 755 DP will be indicated for removal of tattoos of various types and colors, as well as epidermal, pigmented and vascular lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the Crystalase 755 DP laser system.

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/K980710 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980710: Schwartz Electro-Optics, Inc. Crystalase 755 DP Alexandrite Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980710

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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