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CoolMicro Applicator
Model CS-300684 · Zeltiq Aesthetics, Inc. · DI 00816417021206
OOK — Dermal Cooling Pack/Vacuum/Massager · Class II · 21 CFR 878.4340
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.7
2019-03
0
3
2019-04
0
4
2019-05
0
1
2019-06
0
4
2019-07
0
1
2019-08
0
2
2019-09
0
2
2019-10
0
2
2019-12
0
1
2020-02
0
4
2020-03
0
3
2020-04
0
1
2020-07
0
1
2020-11
0
3
2021-01
0
2
2021-02
0
2
2021-03
0
4
2021-04
0
63
2021-05
0
30.5
2021-06
0
22
2021-07
0
7
2021-08
0
6
2021-09
0
12
2021-10
0
5.5
2021-11
0
2
2021-12
0
5
2022-01
0
23
2022-02
0
38
2022-03
0
74
2022-04
0
52
2022-05
0
38
2022-06
0
59
2022-07
0
26
2022-08
0
2.5
2022-09
0
1.5
2022-10
0
2
2022-11
0
2
2022-12
0
1
2023-01
0
1
2023-02
0
1
2023-03
0
1
2023-05
0
1
2023-06
0
320
2023-07
0
112.4
2023-08
0
106.56
2023-09
0
3
2023-10
0
1
2023-11
0
1
2023-12
0
1
2024-03
0
2
2024-04
0
1
2024-05
0
1
2024-06
0
1
2025-01
0
1
2025-02
0
1.5
2025-03
0
2
2025-04
0
18.5
2025-05
0
15.5
2025-06
0
19
2025-07
0
19
2025-08
0
15
2025-09
0
9
2025-10
0
12.5
2025-11
0
13.5
2025-12
0
13.5
2026-01
0
11.5
2026-02
0
10
2026-03
0
10.5
2026-04
0
5.33
2026-05
0
4
2026-06
0
9
This device (reports/month)Average device in OOK (reports/device/month)